AzTrials
AzTrials

Anatomic Stage II Breast Cancer AJCC v8Phase 3NCT04457596

T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive Breast Cancer, the CompassHER2 RD Trial

A Phase 3 study testing Trastuzumab Emtansine, Tucatinib and Questionnaire Administration in people with Anatomic Stage II Breast Cancer AJCC v8 and Anatomic Stage III Breast Cancer AJCC v8, run by Alliance for Clinical Trials in Oncology at 1,176 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This phase III trial compares the effect of usual treatment with trastuzumab emtansine (T-DM1) alone vs. T-DM1 in combination with tucatinib. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called DM1. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Trastuzumab Emtansine, Tucatinib and Questionnaire Administration
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,056 participants
Where
1,176 sitesin 3 countries
Study dates
2 Mar 2021to 31 May 2035
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • HER2-positive status will be based on pretreatment biopsy material and defined as an immunohistochemistry (IHC) score of 3+ and/or positive by in situ hybridization (ISH) according to current American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines. Central testing is not required
  • Known hormone receptor (HR) status as defined by ASCO/CAP guidelines (based on pretreatment biopsy material). Hormone receptor positive status can be determined by either known positive estrogen receptor (ER) or known positive progesterone receptor (PR) status; hormone receptor negative status must be determined by both known negative ER and known negative PR
  • Patients with clinical stage T1-4, N0-3 disease at presentation and residual invasive disease postoperatively as defined above are eligible. Patients with clinical stage TX disease at presentation are also eligible if their pathologic staging meets eligibility criteria. (Note: Patients with T1a/bN0 tumors are not eligible at initial breast cancer diagnosis are not eligible)
  • Patients with residual HR-negative, HER2 (+) disease in the breast and/or lymph nodes per the surgical pathology report are eligible. Patients with HR+ HER2+ disease must have disease in their lymph node(s) per the surgical pathology report in order to qualify for the study. The presence of residual invasive disease in the breast is not mandatory for node-positive patients
  • Patients with weakly ER-positive and/or PR-positive (1-10%) breast cancer (based on the pretreatment core biopsy) are eligible even if they have node-negative disease per the surgical pathology report
  • The residual disease tissue (breast and/or lymph nodes) is not required to be HER2-positive, as eligibility for NCI-2020-03770 (A011801) is based on a positive HER2 status at the time of the initial breast cancer diagnosis
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  • Note: The presence of micrometastases in lymph nodes after preoperative therapy counts as residual disease, whereas the presence of isolated tumor cells does not
  • Patients with synchronous bilateral invasive disease are eligible provided both lesions were confirmed to be HER2-positive, and at least one of the lesions meets the criteria outlined above. Multifocal disease is allowed, as long as the largest biopsied breast tumor was HER2-positive
  • Patients must have received neoadjuvant chemotherapy with one of the following regimens: docetaxel/trastuzumab/pertuzumab (THP), paclitaxel/methotrexate/cisplatin (TMP), doxorubicin/cyclophosphamide/paclitaxel/trastuzumab/pertuzumab (AC-TH(P)); docetaxel/carboplatin/trastuzumab/pertuzumab (TCH(P)); fluorouracil/doxorubicin/cyclophosphamide-docetaxel/trastuzumab/pertuzumab (FAC-TH(P)), or fluorouracil/epirubicin/cyclophosphamide-docetaxel/trastuzumab/pertuzumab (FEC-TH(P)). Note: apart from TCHP, where T is docetaxel, treatment with docetaxel or paclitaxel is acceptable
  • Prior receipt of T-DM1 in the neoadjuvant setting is not allowed.
  • Prior treatment must have consisted of >= 6 cycles of chemotherapy and HER2-directed therapy, with a total duration of >= 12 weeks, including at least 9 weeks of preoperative taxane and trastuzumab with or without pertuzumab (or Food and Drug Administration [FDA]-approved biosimilars). Patients who have received at least 9 weeks of preoperative taxane, pertuzumab and margetuximab are also eligible if they received >= 6 cycles of systemic therapy prior to enrollment. Note: Patients who complete at least nine of a planned twelve doses of weekly paclitaxel, or three of a planned four doses of docetaxel, but discontinue prematurely due to toxicity are eligible. Patients receiving dose-dense chemotherapy regimens are also eligible. Prior use of nab-paclitaxel (Abraxane) instead of paclitaxel or docetaxel is permitted. Prior use of subcutaneous trastuzumab (Hylecta) and subcutaneous trastuzumab and pertuzumab (Phesgo) is also allowed.
  • Patients who received neoadjuvant systemic therapy which included experimental HER2-targeted therapy/therapies are potentially eligible, as long as the investigational agent was not a HER2-targeted antibody-drug conjugate (e.g. T-DM1, DS-8201a [trastuzumab deruxtecan]) or a HER2 targeted tyrosine kinase inhibitor (TKI) (e.g. tucatinib, lapatinib, neratinib).
  • Patients may have received =< 1 cycle of T-DM1 in the adjuvant setting. Note: These patients will be randomized to receive a further 14 cycles of T-DM1 and tucatinib/placebo as tolerated. The most recent cycle of T-DM1 should have been administered =< 5 weeks prior to registration
  • Note: Both of the following two criteria need to be met for the patient to be eligible for this study
  • An interval of no more than 12 weeks between the completion date of the last definitive treatment (e.g. postoperative chemotherapy or radiation, or if neither given, breast surgical date) and the date of registration. Concurrent radiation therapy is permitted while receiving study treatment
  • Patients must be registered on study within =< 180 days of the date of the most recent definitive breast cancer surgery (not including reconstructive surgery)
  • All systemic chemotherapy should have been completed preoperatively unless participating in EA1181 (CompassHER2 pathologic complete response [pCR]) or the BIG DECRESCENDO Trial (which is very similar to CompassHER2 pCR in terms of study design, drugs, and eligibility). However, patients who received 4 cycles of neoadjuvant THP off study can receive a further 2-4 cycles of chemotherapy postoperatively to meet eligibility for A011801. Patients who participated in EA1181 or MA41 and proceeded to surgery immediately after the de-escalated trial regimen must receive postoperative chemotherapy to complete a total of >= 6 cycles of systemic treatment prior to enrollment on A011801, as outlined above (e.g. 4 cycles pre-operatively, and 2 cycles post-operatively). The postoperative chemotherapy regimen prescribed is at the discretion of the treating oncologist (i.e. 2-4 cycles AC or THP, other). Continuation of trastuzumab + pertuzumab (HP) pre- or post-operatively as maintenance therapy (while awaiting a surgical date or an official pathology report) is allowed for all study participants. Note: Treatment received as part of EA1181 (i.e., the number of cycles of pre-operative chemotherapy and HER2-directed therapy) counts towards A011801 eligibility only, and does not count toward the total number of treatment cycles to be administered on A011801.
  • Toxicities related to prior systemic treatment should have resolved or be at baseline, apart from alopecia, peripheral neuropathy =< grade 1, and other AEs not felt to be of clinical significance by the treating physician (e.g. nail changes from prior taxane-based chemotherapy).
  • Adequate excision: surgical removal of all clinically evident disease in the breast and lymph nodes as follows:
  • Breast surgery: total mastectomy with no gross residual disease at the margin of resection, or breast-conserving surgery with histologically negative margins of excision, with the following exception: if the margins of resection include the pectoralis fascia or subcutaneous tissue, and no further surgery can be done to clear that margin, the patient may be enrolled.
  • For patients who undergo breast-conserving surgery, the margins of the resected specimen must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS) as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional operative procedures may be performed to obtain clear margins. If tumor is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible. Patients with margins positive for classic lobular carcinoma in situ (LCIS) are eligible without additional resection
  • Lymph node surgery
  • The axilla needs to be evaluated with either sentinel node biopsy or axillary lymph node dissection. If patients have a sentinel lymph node biopsy and sentinel nodes are negative for residual disease, no further axillary treatment is necessary. If patients have a sentinel lymph node (biopsy and sentinel nodes are positive for residual nodal disease, then ALND) is strongly encouraged. If ALND is not performed, then nodal irradiation to the level I/II is required. If patients have micro- or macro-metastatic nodal disease, regional nodal irradiation is required.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Age >= 18 years
  • Absolute neutrophil count (ANC) >= 1,000/mm^3
  • Hemoglobin >= 8 g/dL (Note: packed red blood cells [PRBC] transfusion is not permitted to achieve eligibility)
  • Platelet count >= 100,000/mm^3
  • Creatinine =< 1.5 x upper limit of normal (ULN)
  • Total bilirubin =< 1.0 x upper limit of normal (ULN) or direct bilirubin within the institutional normal range for patients with Gilbert's syndrome
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN)
  • Screening left ventricular ejection fraction (LVEF) >= 50% on echocardiogram (ECHO) or multiple-gated acquisition (MUGA) after receiving neoadjuvant chemotherapy and no decrease in LVEF by more than 15% absolute percentage points from the pre-chemotherapy LVEF. Or, if pre-chemotherapy LVEF was not assessed, the screening LVEF must be >= 55% after completion of neoadjuvant chemotherapy. Note: LVEF assessment may be repeated once up to 3 weeks following the initial screening assessment to assess eligibility.
  • Screening assessment refers to the assessment done after the completion of neoadjuvant treatment but before the date of A011801 registration ** Pre-chemotherapy assessment refers to the assessment done before the start of neoadjuvant treatment

Who cannot join

  • No adjuvant treatment with any anti-cancer investigational drug within 28 days prior to registration
  • Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative serum pregnancy test done =< 7 days prior to registration is required
  • Patients with known active and/or untreated hepatitis B or hepatitis C or chronic liver disease are ineligible. Patients with a diagnosis of hepatitis B or C that has been treated and cleared and normal liver function are eligible to participate in the study if the other eligibility parameters are met
  • Stage IV (metastatic) breast cancer
  • History of any prior (ipsi- or contralateral) invasive breast cancer within 3 years of registration
  • Patients with ER+ HER2+ residual invasive disease that is lymph node-negative per the surgical pathology report
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  • Evidence of recurrent disease following preoperative therapy and surgery
  • Patients for whom radiotherapy would be recommended for breast cancer treatment but for whom it is contraindicated because of medical reasons (e.g., connective tissue disorder or prior ipsilateral breast radiation). Patients who refuse a recommended course of radiotherapy are also excluded.
  • History of exposure to the following cumulative doses of anthracyclines: doxorubicin > 240 mg/m^2; epirubicin or liposomal doxorubicin-hydrochloride (Myocet) > 480 mg/m^2. For other anthracyclines, exposure equivalent to doxorubicin > 240 mg/m^2
  • Cardiopulmonary dysfunction as defined by any of the following:
  • History of National Cancer Institute (NCI) CTCAE version (v) 5.0 grade >= 3 symptomatic congestive heart failure (CHF) or New York Heart Association (NYHA) criteria class >= II
  • Angina pectoris requiring anti-anginal medication, serious cardiac arrhythmia not controlled by adequate medication, severe conduction abnormality, or clinically significant valvular disease
  • High-risk uncontrolled arrhythmias: i.e., atrial tachycardia with a heart rate > 100/min at rest, significant ventricular arrhythmia (ventricular tachycardia) or higher-grade atrioventricular block (AV)-block (second degree AV-block type 2 [Mobitz 2] or third degree AV-block)
  • Significant symptoms (grade >= 2) relating to left ventricular dysfunction, cardiac arrhythmia, or cardiac ischemia while or since receiving preoperative therapy
  • History of a decrease in left ventricular ejection fraction (LVEF) to < 40% with prior trastuzumab treatment (e.g., during preoperative therapy)
  • Uncontrolled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg)
  • Current severe, uncontrolled systemic disease
  • Major surgical procedure unrelated to breast cancer or significant traumatic injury within 28 days prior to registration or anticipation of the need for major surgery during the course of study treatment. Laparoscopic or vaginal hysterectomies and reconstructive surgery are not considered major surgeries for the purposes of study eligibility.
  • History of intolerance, including grade 3 to 4 infusion reaction or hypersensitivity to trastuzumab or murine proteins or any components of the product
  • Peripheral neuropathy of any etiology that exceeds grade 1
  • Assessment by the investigator as being unable or unwilling to comply with the requirements of the protocol
  • Use of a strong CYP3A4 or CYP2C8 inhibitor within 2 weeks, or use of a strong CYP3A4 or CYP2C8 inducer within 5 days prior to registration is prohibited.
  • Please note that use of sensitive CYP3A substrates should be avoided two weeks before registration and during study treatment. Additionally, CYP3A4 or CYP2C8 inducers are prohibited as concomitant medications within 5 days following discontinuation of tucatinib treatment. Patients who require medications that are known to be sensitive substrates of CYP3A4 with a narrow therapeutic window should be excluded.

Trial locations and contacts

1,176 sites in 3 countries.

316 sites in 3 countries

United States300 sites

  • Hawaii Cancer Care - Westridge

    ‘Aiea, Hawaii, 96701

  • Pali Momi Medical Center

    ‘Aiea, Hawaii, 96701

  • Queen's Cancer Center - Pearlridge

    ‘Aiea, Hawaii, 96701

  • The Cancer Center of Hawaii-Pali Momi

    ‘Aiea, Hawaii, 96701

  • Avera Cancer Institute-Aberdeen

    Aberdeen, South Dakota, 57401

  • Providence Regional Cancer System-Aberdeen

    Aberdeen, Washington, 98520

  • Hickman Cancer Center

    Adrian, Michigan, 49221

  • Riverwood Healthcare Center

    Aitkin, Minnesota, 56431

  • Phoebe Putney Memorial Hospital

    Albany, Georgia, 31701

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

  • Presbyterian Kaseman Hospital

    Albuquerque, New Mexico, 87110

  • University Cancer Specialists - Alcoa

    Alcoa, Tennessee, 37701

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

  • Aultman Alliance Community Hospital

    Alliance, Ohio, 44601

  • AdventHealth Altamonte

    Altamonte Springs, Florida, 32701

  • Saint Anthony's Health

    Alton, Illinois, 62002

  • UPMC Altoona

    Altoona, Pennsylvania, 16601

  • The Don and Sybil Harrington Cancer Center

    Amarillo, Texas, 79106

  • Mary Greeley Medical Center

    Ames, Iowa, 50010

  • McFarland Clinic - Ames

    Ames, Iowa, 50010

  • Community Hospital of Anaconda

    Anaconda, Montana, 59711

  • Anchorage Associates in Radiation Medicine

    Anchorage, Alaska, 98508

  • Anchorage Radiation Therapy Center

    Anchorage, Alaska, 99504

  • Alaska Breast Care and Surgery LLC

    Anchorage, Alaska, 99508

  • Alaska Oncology and Hematology LLC

    Anchorage, Alaska, 99508

  • Alaska Women's Cancer Care

    Anchorage, Alaska, 99508

  • Anchorage Oncology Centre

    Anchorage, Alaska, 99508

  • Katmai Oncology Group

    Anchorage, Alaska, 99508

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

  • Mission Cancer and Blood - Ankeny

    Ankeny, Iowa, 50023

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    Ann Arbor, Michigan, 48106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Luminis Health Anne Arundel Medical Center

    Annapolis, Maryland, 21401

  • Langlade Hospital and Cancer Center

    Antigo, Wisconsin, 54409

  • ThedaCare Regional Cancer Center

    Appleton, Wisconsin, 54911

  • Ascension Saint Elizabeth Hospital

    Appleton, Wisconsin, 54915

  • Northwest Community Hospital

    Arlington Heights, Illinois, 60005

  • Mission Hope Medical Oncology - Arroyo Grande

    Arroyo Grande, California, 93420

  • PCR Oncology

    Arroyo Grande, California, 93420

  • Cone Health Cancer Center at Asheboro

    Asheboro, North Carolina, 27203

  • Randolph Health Cancer Center

    Asheboro, North Carolina, 27203

  • Randolph Hospital

    Asheboro, North Carolina, 27203

  • King's Daughter's Medical Center

    Ashland, Kentucky, 41101

  • Duluth Clinic Ashland

    Ashland, Wisconsin, 54806

  • Northwest Wisconsin Cancer Center

    Ashland, Wisconsin, 54806

  • University Cancer and Blood Center LLC

    Athens, Georgia, 30607

  • Grady Health System

    Atlanta, Georgia, 30303

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

  • Northside Hospital

    Atlanta, Georgia, 30342

  • Sutter Auburn Faith Hospital

    Auburn, California, 95602

  • Sutter Cancer Centers Radiation Oncology Services-Auburn

    Auburn, California, 95603

  • Hematology Oncology Associates of Central New York-Auburn

    Auburn, New York, 13021

  • MultiCare Auburn Medical Center

    Auburn, Washington, 98001

  • Augusta Oncology Associates PC-D'Antignac

    Augusta, Georgia, 30901

  • Augusta Oncology Associates PC-Wheeler

    Augusta, Georgia, 30909

  • Harold Alfond Center for Cancer Care

    Augusta, Maine, 04330

  • Rocky Mountain Cancer Centers-Aurora

    Aurora, Colorado, 80012

  • The Medical Center of Aurora

    Aurora, Colorado, 80012

  • UCHealth University of Colorado Hospital

    Aurora, Colorado, 80045

  • Rush - Copley Medical Center

    Aurora, Illinois, 60504

  • Mount Sinai Comprehensive Cancer Center at Aventura

    Aventura, Florida, 33180

  • UM Sylvester Comprehensive Cancer Center at Aventura

    Aventura, Florida, 33180

  • Saint Alphonsus Cancer Care Center-Baker City

    Baker City, Oregon, 97814

  • Saint Louis Cancer and Breast Institute-Ballwin

    Ballwin, Missouri, 63011

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

  • MedStar Franklin Square Medical Center/Weinberg Cancer Institute

    Baltimore, Maryland, 21237

  • MedStar Good Samaritan Hospital

    Baltimore, Maryland, 21239

  • Kaiser Permanente-Woodlawn Medical Center

    Baltimore, Maryland, 21244

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287

  • Flaget Memorial Hospital

    Bardstown, Kentucky, 40004

  • Advocate Good Shepherd Hospital

    Barrington, Illinois, 60010

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

  • Northwell Health Imbert Cancer Center

    Bay Shore, New York, 11706

  • Houston Methodist San Jacinto Hospital

    Baytown, Texas, 77521

  • Beaufort Memorial Hospital

    Beaufort, South Carolina, 29902

  • UPMC-Heritage Valley Health System Beaver

    Beaver, Pennsylvania, 15009

  • Indu and Raj Soin Medical Center

    Beavercreek, Ohio, 45431

  • UM Upper Chesapeake Medical Center

    Bel Air, Maryland, 21014

  • Nebraska Medicine-Bellevue

    Bellevue, Nebraska, 68123

  • Overlake Medical Center

    Bellevue, Washington, 98004

  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington, 98225

  • Strecker Cancer Center-Belpre

    Belpre, Ohio, 45714

  • Sanford Joe Lueken Cancer Center

    Bemidji, Minnesota, 56601

  • Saint Charles Health System

    Bend, Oregon, 97701

  • UCSF Cancer Center - Berkeley

    Berkeley, California, 94702

  • Alta Bates Summit Medical Center-Herrick Campus

    Berkeley, California, 94704

  • Summit Medical Group

    Berkeley Heights, New Jersey, 07922

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889-5600

  • Lehigh Valley Hospital - Muhlenberg

    Bethlehem, Pennsylvania, 18017

  • Beverly Hospital

    Beverly, Massachusetts, 01915

  • Tower Cancer Research Foundation

    Beverly Hills, California, 90211

  • MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford

    Biddeford, Maine, 04005

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Saint Vincent Healthcare

    Billings, Montana, 59101

  • Saint Vincent Frontier Cancer Center

    Billings, Montana, 59102

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

  • Saint Joseph's/Candler - Bluffton Campus

    Bluffton, South Carolina, 29910

  • Saint Elizabeth Boardman Hospital

    Boardman, Ohio, 44512

  • Boca Raton Regional Hospital

    Boca Raton, Florida, 33486

  • Prisma Health Cancer Institute - Spartanburg

    Boiling Springs, South Carolina, 29316

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho, 83712

  • Central Care Cancer Center - Bolivar

    Bolivar, Missouri, 65613

  • McFarland Clinic - Boone

    Boone, Iowa, 50036

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Boulder Community Foothills Hospital

    Boulder, Colorado, 80303

  • Rocky Mountain Cancer Centers-Boulder

    Boulder, Colorado, 80304

  • Bozeman Health Deaconess Hospital

    Bozeman, Montana, 59715

  • Essentia Health Saint Joseph's Medical Center

    Brainerd, Minnesota, 56401

  • Harrison HealthPartners Hematology and Oncology-Bremerton

    Bremerton, Washington, 98310

  • Lafayette Family Cancer Center-EMMC

    Brewer, Maine, 04412

  • Hartford HealthCare - Saint Vincent's Medical Center

    Bridgeport, Connecticut, 06606

  • Trinity Health IHA Medical Group Hematology Oncology - Brighton

    Brighton, Michigan, 48114

  • Trinity Health Medical Center - Brighton

    Brighton, Michigan, 48114

  • Wellmont Medical Associates-Bristol

    Bristol, Virginia, 24201

  • Ascension Southeast Wisconsin Hospital - Elmbrook Campus

    Brookfield, Wisconsin, 53045

  • Crozer-Keystone Regional Cancer Center at Broomall

    Broomall, Pennsylvania, 19008

  • Saint Joseph Regional Cancer Center

    Bryan, Texas, 77802

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, 91505

  • Highline Medical Center-Main Campus

    Burien, Washington, 98166

  • Kaiser Permanente-Burke Medical Center

    Burke, Virginia, 22015

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01805

  • Cone Health Cancer Center at Alamance Regional

    Burlington, North Carolina, 27215

  • Aurora Cancer Care-Southern Lakes VLCC

    Burlington, Wisconsin, 53105

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Minnesota Oncology - Burnsville

    Burnsville, Minnesota, 55337

  • UPMC Hillman Cancer Center at Butler Health System

    Butler, Pennsylvania, 16001

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, Idaho, 83605

  • Cambridge Medical Center

    Cambridge, Minnesota, 55008

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

  • Sutter Cancer Centers Radiation Oncology Services-Cameron Park

    Cameron Park, California, 95682

  • UPMC Camp Hill

    Camp Hill, Pennsylvania, 17011

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • Trinity Health IHA Medical Group Hematology Oncology - Canton

    Canton, Michigan, 48188

  • Trinity Health Medical Center - Canton

    Canton, Michigan, 48188

  • Cleveland Clinic Mercy Hospital

    Canton, Ohio, 44708

  • Mercy Hematology and Oncology Associates Inc

    Canton, Ohio, 44708

  • Aultman Health Foundation

    Canton, Ohio, 44710

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Southeast Cancer Center

    Cape Girardeau, Missouri, 63703

  • Memorial Hospital of Carbondale

    Carbondale, Illinois, 62902

  • Carlisle Regional Cancer Center

    Carlisle, Pennsylvania, 17015

  • IU Health North Hospital

    Carmel, Indiana, 46032

  • Mercy Cancer Center - Carmichael

    Carmichael, California, 95608

  • Mercy San Juan Medical Center

    Carmichael, California, 95608

  • Caro Cancer Center

    Caro, Michigan, 48723

  • Saint Anthony Regional Hospital

    Carroll, Iowa, 51401

  • Carson Tahoe Regional Medical Center

    Carson City, Nevada, 89703

  • SIH Cancer Institute

    Carterville, Illinois, 62918

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • Rex Hematology Oncology Associates-Cary

    Cary, North Carolina, 27518

  • Eden Hospital Medical Center

    Castro Valley, California, 94546

  • Physicians' Clinic of Iowa PC

    Cedar Rapids, Iowa, 52402

  • Mercy Hospital

    Cedar Rapids, Iowa, 52403

  • Oncology Associates at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • AdventHealth Celebration

    Celebration, Florida, 34747

  • Rocky Mountain Cancer Centers - Centennial

    Centennial, Colorado, 80112

  • Dayton Physicians LLC-Miami Valley South

    Centerville, Ohio, 45459

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

  • Providence Regional Cancer System-Centralia

    Centralia, Washington, 98531

  • Christiana Care Health System-Concord Health Center

    Chadds Ford, Pennsylvania, 19317

  • Chambersburg Hospital

    Chambersburg, Pennsylvania, 17201

  • WellSpan Medical Oncology and Hematology

    Chambersburg, Pennsylvania, 17201

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • West Virginia University Charleston Division

    Charleston, West Virginia, 25304

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina, 28204

  • Chelsea Hospital

    Chelsea, Michigan, 48118

  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

    Chelsea, Michigan, 48118

  • Cancer Specialists of Tidewater Limited

    Chesapeake, Virginia, 23320

  • Saint Luke's Hospital

    Chesterfield, Missouri, 63017

  • Cheyenne Regional Medical Center-West

    Cheyenne, Wyoming, 82001

  • Mount Sinai Hospital Medical Center

    Chicago, Illinois, 60608

  • Northwestern University

    Chicago, Illinois, 60611

  • John H Stroger Jr Hospital of Cook County

    Chicago, Illinois, 60612

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Illinois

    Chicago, Illinois, 60612

  • Swedish Covenant Hospital

    Chicago, Illinois, 60625

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Ascension Calumet Hospital

    Chilton, Wisconsin, 53014

  • The Christ Hospital

    Cincinnati, Ohio, 45219

  • Good Samaritan Hospital - Cincinnati

    Cincinnati, Ohio, 45220

  • Oncology Hematology Care Inc-Kenwood

    Cincinnati, Ohio, 45236

  • Bethesda North Hospital

    Cincinnati, Ohio, 45242

  • TriHealth Cancer Institute-Westside

    Cincinnati, Ohio, 45247

  • TriHealth Cancer Institute-Anderson

    Cincinnati, Ohio, 45255

  • Siteman Cancer Center at Saint Peters Hospital

    City of Saint Peters, Missouri, 63376

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

  • Providence Cancer Institute Clackamas Clinic

    Clackamas, Oregon, 97015

  • Hematology Oncology Consultants-Clarkston

    Clarkston, Michigan, 48346

  • Newland Medical Associates-Clarkston

    Clarkston, Michigan, 48346

  • Morton Plant Hospital

    Clearwater, Florida, 33756

  • Southeastern Medical Oncology Center-Clinton

    Clinton, North Carolina, 28328

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

  • Mission Cancer and Blood - West Des Moines

    Clive, Iowa, 50325

  • Community Cancer Institute

    Clovis, California, 93611

  • Billings Clinic-Cody

    Cody, Wyoming, 82414

  • Kootenai Health - Coeur d'Alene

    Coeur d'Alene, Idaho, 83814

  • Main Line Health Center-Collegeville

    Collegeville, Pennsylvania, 19426

  • Baptist Memorial Hospital and Cancer Center-Collierville

    Collierville, Tennessee, 38017

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • Rocky Mountain Cancer Centers-Penrose

    Colorado Springs, Colorado, 80907

  • UCHealth Memorial Hospital Central

    Colorado Springs, Colorado, 80909

  • Memorial Hospital North

    Colorado Springs, Colorado, 80920

  • MU Health - University Hospital/Ellis Fischel Cancer Center

    Columbia, Missouri, 65212

  • Baptist Memorial Hospital and Cancer Center-Golden Triangle

    Columbus, Mississippi, 39705

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Mount Carmel East Hospital

    Columbus, Ohio, 43213

  • Columbus Oncology and Hematology Associates Inc

    Columbus, Ohio, 43214

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Grant Medical Center

    Columbus, Ohio, 43215

  • The Mark H Zangmeister Center

    Columbus, Ohio, 43219

  • Mount Carmel Health Center West

    Columbus, Ohio, 43222

  • Doctors Hospital

    Columbus, Ohio, 43228

  • John Muir Medical Center-Concord

    Concord, California, 94520

  • New Hampshire Oncology Hematology PA-Concord

    Concord, New Hampshire, 03301

  • MD Anderson in The Woodlands

    Conroe, Texas, 77384

  • Cookeville Regional Medical Center

    Cookeville, Tennessee, 38501

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Bay Area Hospital

    Coos Bay, Oregon, 97420

  • UM Sylvester Comprehensive Cancer Center at Coral Gables

    Coral Gables, Florida, 33146

  • Baptist Health Corbin

    Corbin, Kentucky, 40701

  • Commonwealth Cancer Center-Corbin

    Corbin, Kentucky, 40701

  • UC Irvine Health Cancer Center-Newport

    Costa Mesa, California, 92627

  • Alegent Health Mercy Hospital

    Council Bluffs, Iowa, 51503

  • Heartland Oncology and Hematology LLP

    Council Bluffs, Iowa, 51503

  • Methodist Jennie Edmundson Hospital

    Council Bluffs, Iowa, 51503

  • UPMC Hillman Cancer Center - Passavant - Cranberry

    Cranberry Township, Pennsylvania, 16066

  • Greater Regional Medical Center

    Creston, Iowa, 50801

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141

  • AMG Crystal Lake - Oncology

    Crystal Lake, Illinois, 60014

  • Aurora Saint Luke's South Shore

    Cudahy, Wisconsin, 53110

  • UPMC Western Maryland

    Cumberland, Maryland, 21502

  • Parkland Memorial Hospital

    Dallas, Texas, 75235

  • UT Southwestern Simmons Cancer Center - RedBird

    Dallas, Texas, 75237

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

  • Danbury Hospital

    Danbury, Connecticut, 06810

  • Carle at The Riverfront

    Danville, Illinois, 61832

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Genesis Medical Center - East Campus

    Davenport, Iowa, 52803

  • Genesis Cancer Care Institute

    Davenport, Iowa, 52804

  • Iowa Cancer Specialists

    Davenport, Iowa, 52807

  • Sutter Davis Hospital

    Davis, California, 95616

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Premier Blood and Cancer Center

    Dayton, Ohio, 45409

  • Dayton Physician LLC - Englewood

    Dayton, Ohio, 45415

  • Miami Valley Hospital North

    Dayton, Ohio, 45415

  • Corewell Health Dearborn Hospital

    Dearborn, Michigan, 48124

  • Atlanta VA Medical Center

    Decatur, Georgia, 30033

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Essentia Health - Deer River Clinic

    Deer River, Minnesota, 56636

  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach

    Deerfield Beach, Florida, 33442

  • Northwestern Medicine Cancer Center Kishwaukee

    DeKalb, Illinois, 60115

  • Delaware Health Center-Grady Cancer Center

    Delaware, Ohio, 43015

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Cancer Center of Colorado at Sloan's Lake

    Denver, Colorado, 80204

  • National Jewish Health-Main Campus

    Denver, Colorado, 80206

  • UCHealth - Cherry Creek

    Denver, Colorado, 80206

  • The Women's Imaging Center

    Denver, Colorado, 80209

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

  • Presbyterian - Saint Lukes Medical Center - Health One

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers-Midtown

    Denver, Colorado, 80218

  • SCL Health Saint Joseph Hospital

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers-Rose

    Denver, Colorado, 80220

  • Rose Medical Center

    Denver, Colorado, 80220

  • Western Surgical Care

    Denver, Colorado, 80220

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Mission Cancer and Blood - Des Moines

    Des Moines, Iowa, 50309

  • Broadlawns Medical Center

    Des Moines, Iowa, 50314

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Mission Cancer and Blood - Laurel

    Des Moines, Iowa, 50314

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Ascension Saint John Hospital

    Detroit, Michigan, 48236

  • Essentia Health Saint Mary's - Detroit Lakes Clinic

    Detroit Lakes, Minnesota, 56501

  • Illinois CancerCare-Dixon

    Dixon, Illinois, 61021

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • Advocate Good Samaritan Hospital

    Downers Grove, Illinois, 60515

  • Delaware County Memorial Hospital

    Drexel Hill, Pennsylvania, 19026

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • Epic Care-Dublin

    Dublin, California, 94568

  • Kaiser Permanente Dublin

    Dublin, California, 94568

  • Columbus Oncology and Hematology Associates

    Dublin, Ohio, 43016

Other trials in United States

Canada9 sites

  • London Regional Cancer Program

    London, Ontario, N6A 4L6

  • Lakeridge Health Oshawa

    Oshawa, Ontario, L1G 2B9

  • CHU de Quebec-Hopital du Saint-Sacrement (HSS)

    Québec, Quebec, G1S 4L8

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Atlantic Health Sciences Corporation-Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • Odette Cancer Centre- Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • Saint Michael's Hospital

    Toronto, Ontario, M5B 1W8

  • BCCA-Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Puerto Rico7 sites

  • Cancer Center-Metro Medical Center Bayamon

    Bayamón, 00959-5060

  • Puerto Rico Hematology Oncology Group

    Bayamón, 00961

  • Doctors Cancer Center

    Manati, 00674

  • San Juan Community Oncology Group

    San Juan, 00917

  • Centro Comprensivo de Cancer de UPR

    San Juan, 00927

  • PROncology

    San Juan, 00927

  • San Juan City Hospital

    San Juan, 00936

Other trials in Puerto Rico

About this study

Official title: The CompassHER2 Trials (COMprehensive Use of Pathologic Response ASSessment to Optimize Therapy in HER2-Positive Breast Cancer): CompassHER2 Residual Disease (RD), A Double-Blinded, Phase III Randomized Trial of T-DM1 and Placebo Compared With T-DM1 and Tucatinib

This phase III trial compares the effect of usual treatment with trastuzumab emtansine (T-DM1) alone vs. T-DM1 in combination with tucatinib. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib is in a class of medications called kinase inhibitors. It blocks HER2, which may help keep cancer cells from growing and may kill them. Giving T-DM1 in combination with tucatinib may work better in preventing breast cancer from relapsing in patients with HER2 positive breast cancer compared to T-DM1 alone.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine if the invasive disease-free survival (iDFS) with T-DM1 and tucatinib is superior to the iDFS in the control arm (T-DM1 + placebo) when administered to high risk patients with HER2-positive breast cancer and residual disease after neoadjuvant HER2-directed therapy.

SECONDARY OBJECTIVES:

  1. To evaluate whether treatment with tucatinib plus T-DM1 compared to treatment with T-DM1 alone (T-DM1 plus placebo) improves the following:

Ia. Overall survival (OS). Ib. Breast cancer-free survival (BCFS). Ic. Disease recurrence-free survival (DRFS) Id. Disease-free survival (DFS) Ie. Brain metastases-free survival (BMFS).

II. To evaluate whether treatment with tucatinib plus T-DM1 compared to treatment with T-DM1 alone (T-DM1 plus placebo) reduces the incidence of brain metastases.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive T-DM1 intravenously (IV) over 30-90 minutes on day 1 and placebo orally (PO) twice daily (BID) on days 1-21. Treatment repeats every 21 days for up to 14 cycles in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive T-DM1 IV over 30-90 minutes on day 1 and tucatinib PO BID on days 1-21. Treatment repeats every 21 days for up to 14 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days, then every 6 months for 10 years after registration.

Being tested
Trastuzumab Emtansine, Placebo Administration, Tucatinib, Questionnaire Administration, Quality-of-Life Assessment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trastuzumab EmtansineBiological

    Given IV

  • Placebo AdministrationDrug

    Given PO

  • TucatinibDrug

    Given PO

  • Questionnaire AdministrationOther

    Ancillary studies

  • Quality-of-Life AssessmentOther

    Ancillary studies

Study groups in NCT04457596
Study groupRoleWhat they receive
Arm I (trastuzumab emtansine, placebo)Active comparatorPatients receive T-DM1 IV over 30-90 minutes on day 1 and placebo PO BID on days 1-21. Treatment repeats every 21 days for up to 14 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography/multigated acquisition (MUGA) scan and blood sample collection throughout the study. Patients undergo echocardiography/multigated acquisition (MUGA) scan and blood sample collection throughout the study.
Receives: Biological: Trastuzumab Emtansine; Drug: Placebo Administration; Other: Questionnaire Administration; Other: Quality-of-Life Assessment
Arm II (trastuzumab emtansine, tucatinib)ExperimentalPatients receive T-DM1 IV over 30-90 minutes on day 1 and tucatinib PO BID on days 1-21. Treatment repeats every 21 days for up to 14 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography/multigated acquisition (MUGA) scan and blood sample collection throughout the study.
Receives: Biological: Trastuzumab Emtansine; Drug: Tucatinib; Other: Questionnaire Administration; Other: Quality-of-Life Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Modified invasive disease-free survival (iDFS)

    A Kaplan-Meier method will be used to estimate the survival curves and a stratified log-rank test will be used to compare the invasive disease-free survival (iDFS) of the two arms. A stratified Cox model will be used to estimate the hazard ratio. If there appears to be clinically significant imbalances of baseline variables between the treatment arms, a secondary analysis of the primary endpoint will use stratified Cox model to compare the treatment effects that include the variables that are deemed imbalanced between the arms as adjusting variables. The randomization stratification variables will be the stratified variables in the model.

    Measured: From randomization to one of the following events: invasive local, regional or distant recurrence, invasive contralateral breast cancer or death from any cause, assessed up to 10 years

Secondary outcomes (7)

  1. Unmodified invasive disease-free survival (iDFS)

    Will be defined as the time from randomization to one of the following events: invasive local, regional or distant recurrence, invasive contralateral breast cancer secondary primary invasive cancer (other than basal or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix), or death from any cause, assessed up to 10 years. A Kaplan-Meier method will be used to estimate the survival curves and a stratified log-rank test will be used to compare the iDFS of the two arms. A stratified Cox model will be used to estimate the hazard ratio.

    Measured: Up to 10 years

  2. Breast cancer-free survival

    Will be summarized with Kaplan-Meier curves and compared between the arms using a stratified log-rank test and stratified Cox model. If there are clinically significant imbalances in baseline characteristics between the treatment arms, a second analysis will be done using a stratified Cox model with the variables that are imbalance added as adjusting variables.

    Measured: From randomization to invasive local, regional, or distant recurrence, or invasive contralateral breast cancer, assessed up to 10 years

  3. Distant recurrence-free survival

    Will be summarized with Kaplan-Meier curves and compared between the arms using a stratified log-rank test and stratified Cox model. If there are clinically significant imbalances in baseline characteristics between the treatment arms, a second analysis will be done using a stratified Cox model with the variables that are imbalanced added as adjusting variables.

    Measured: From randomization to the first incidence of distant recurrence, assessed up to 10 years

  4. Overall survival

    Will be summarized with Kaplan-Meier curves and compared between the arms using a stratified log-rank test and stratified Cox model. If there are clinically significant imbalances in baseline characteristics between the treatment arms, a second analysis will be done using a stratified Cox model with the variables that are imbalance added as adjusting variables.

    Measured: From randomization until death from any cause, assessed up to 10 years

  5. Brain metastases-free survival

    Will be summarized with Kaplan-Meier curves and compared between the arms using a stratified log-rank test and stratified Cox model. If there are clinically significant imbalances in baseline characteristics between the treatment arms, a second analysis will be done using a stratified Cox model with the variables that are imbalance added as adjusting variables.

    Measured: From randomization to documentation of involvement of the central nervous system by metastatic cancer including parenchymal brain and spinal cord metastases as well as leptomeningeal carcinomatosis, assessed up to 10 years

  6. Incidence of brain metastases

    An incident of brain metastases is documentation of involvement of the central nervous system by metastatic cancer including parenchymal brain and spinal cord metastases as well as leptomeningeal carcinomatosis. The cumulative incidence of brain metastases will be determined as the crude cumulative incidence as well as with incidence with competing risks where the competing event is death.

    Measured: Up to 10 years

  7. Disease-free survival

    Will be summarized with Kaplan-Meier curves and compared between the arms using a stratified log-rank test and stratified Cox model. If there are clinically significant imbalances in baseline characteristics between the treatment arms, a second analysis will be done using a stratified Cox model with the variables that are imbalance added as adjusting variables.

    Measured: From randomization to the first incidence of invasive local, regional, or distant recurrence, second primary non-breast cancer event, or contralateral or ipsilateral ductal carcinoma in situ, assessed up to 10 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2020
  2. Study start2 Mar 2021
  3. Primary completion31 Jan 2028 (estimated)
  4. Study completion31 May 2035 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,056 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04457596
Sponsor's protocol ID
A011801
Other IDs
U10CA180821, NCI-2020-03770
Status last verified
Oct 2025
First submitted
30 Jun 2020
Last updated
15 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Boman C, Tranchell C, Liu X, Eriksson Bergman L, Toli MA, Bergh J, Foukakis T, Matikas A. Prognosis After Pathologic Complete Response to Neoadjuvant Therapy in Early-Stage Breast Cancer: A Population-Based Study. J Natl Compr Canc Netw. 2025 Mar 12;23(4):e247093. doi: 10.6004/jnccn.2024.7093.

    PubMed 40073831

  • O'Sullivan CC, Ballman KV, McCall L, Kommalapati A, Zemla T, Weiss A, Mitchell M, Blinder V, Tung NM, Irvin WJ, Lee M, Goetz MP, Symmans WF, Borges VF, Krop I, Carey LA, Partridge AH. Alliance A011801 (compassHER2 RD): postneoadjuvant T-DM1 + tucatinib/placebo in patients with residual HER2-positive invasive breast cancer. Future Oncol. 2021 Dec;17(34):4665-4676. doi: 10.2217/fon-2021-0753. Epub 2021 Oct 12.

    PubMed 34636255

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Trastuzumab Emtansine, Tucatinib and Questionnaire Administration in people with Anatomic Stage II Breast Cancer AJCC v8 and Anatomic Stage III Breast Cancer AJCC v8, run by Alliance for Clinical Trials in Oncology at 1,176 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 33 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1,176 sites in United States, Canada, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modified invasive disease-free survival (iDFS) (time frame: From randomization to one of the following events: invasive local, regional or distant recurrence, invasive contralateral breast cancer or death from any cause, assessed up to 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04457596, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.

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