AzTrials
AzTrials

Breast CancerPhase 2NCT04893109

ATEMPT 2.0: Adjuvant T-DM1 vs TH

A Phase 2 study testing trastuzumab-emtansine, Trastuzumab SC and Paclitaxel in people with Breast Cancer and HER2-positive Breast Cancer, run by Dana-Farber Cancer Institute at 53 sites in United States.

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Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This research study is studying how well newly diagnosed breast cancer that has tested positive for a protein called HER2 responds using one of two different combination of HER2-directed therapies as a treatment after surgery. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer, HER2-positive Breast Cancer
What is being tested?
trastuzumab-emtansine, Trastuzumab SC and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
53 sitesUnited States
Study dates
16 Jun 2021to 1 May 2029
Phase
Phase 2
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

  • Patients must have HER2-positive Stage I histologically confirmed invasive carcinoma of the breast. Patients must have node-negative (N0) or micrometastases (N1mic) breast cancer according to the AJCC 8th edition anatomic staging table.
  • If the patient has had a negative sentinel node biopsy, then no further axillary dissection is required, and the patient is determined to be node-negative. If an axillary dissection without sentinel lymph node biopsy is performed to determine nodal status, at least six axillary lymph nodes must be removed and analyzed, and determined to be negative, for the patient to be considered node-negative. Axillary nodes with single cells or tumor clusters ≤ 0.2 mm by either H\&E or immunohistochemistry (IHC) will be considered node-negative.
  • Any axillary lymph node with tumor clusters between 0.02 and 0.2 cm is considered a micrometastasis. Patients with a micrometastasis are eligible. An axillary dissection is not required to be performed in patients with a micrometastasis found by sentinel node evaluation. In cases where the specific pathologic size of lymph node involvement is subject to interpretation, the principal investigator will make the final determination as to eligibility. The investigator must document approval in the patient medical record.
  • Patients who have an area of a T1aN0, ER+ (defined as >10%), HER2-negative cancer in addition to their primary HER2-positive tumor are eligible.
  • HER2-positive by ASCO CAP 2018 guidelines, confirmed by central testing. NOTE: HER-2 status must be confirmed to be positive by central review by NeoGenomics prior to patient starting protocol therapy. Patients previously having had HER2 immunohistochemical testing by NeoGenomics do not need to undergo retesting for central confirmation of HER2 status.
  • NOTE: DCIS components will not be counted in the determination of HER2 status
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  • ER/PR determination is required. ER and PR assays should be performed by immunohistochemical methods according to the local institution standard protocol.
  • Bilateral breast cancers that individually meet eligibility criteria are allowed.
  • Patients with multifocal or multicentric disease are eligible, as long as each tumor individually meets eligibility criteria. Central confirmation is needed for any site of disease that is tested to be HER2-positive by local testing (unless testing was previously done by NeoGenomics).
  • Patients with a history of ipsilateral DCIS are eligible if they were treated with wide excision alone, without radiation therapy, or treated with a mastectomy for this current breast cancer. Patients with a history of contralateral DCIS are not eligible.
  • ≤ 90 days between the planned treatment start date and the patient's most recent breast surgery for this breast cancer
  • ≥ 18 years of age with any menopausal status.
  • ECOG Performance Status 0 or 1
  • All tumor should be removed by either a modified radical mastectomy or a segmental mastectomy (lumpectomy), with either a sentinel node biopsy or axillary dissection
  • All margins should be clear of invasive cancer or DCIS (i.e. no tumor on ink). The local pathologist must document negative margins of resection in the pathology report. If all other margins are clear, a positive posterior (deep) margin is permitted, provided the surgeon documents that the excision was performed down to the pectoral fascia and all tumor has been removed. Likewise, if all other margins are clear, a positive anterior (superficial; abutting skin) margin is permitted provided the surgeon documents that all tumor has been removed.
  • Patients undergoing breast conservation therapy (i.e. lumpectomy) must not have any contraindications to radiation therapy. Radiation to the conserved breast is required.
  • Patients may have received up to 4 weeks of tamoxifen therapy, or other hormonal therapy, for adjuvant therapy for this cancer. Patients cannot receive adjuvant hormonal therapy during protocol treatment for the first 12 weeks.
  • Prior oophorectomy for cancer prevention is allowed.
  • Patients who have undergone partial breast radiation (duration ≤ 14 days) prior to registration are eligible. Partial breast radiation must be completed prior to 2 weeks before starting protocol therapy. Patients who have undergone whole breast radiation are not eligible.
  • Patients who have participated in a window study (treatment with an investigational agent prior to surgery for ≤ 2 weeks) are eligible. Patients must have discontinued the investigational agent at least 14 days before participation.
  • Adequate bone marrow function:
  • ANC ≥ 1000/mm3,
  • Hemoglobin ≥ 9 g/dl
  • Platelets ≥ 100,000/mm3
  • Adequate hepatic function:
  • Total bilirubin ≤ 1.2mg/dL
  • AST and ALT ≤ 1.5x Institutional ULN
  • For patients with Gilbert syndrome, the direct bilirubin should be within the institutional normal range. Serum alkaline phosphatase should be ≤ 1.5x Institutional ULN.
  • Left ventricular ejection fraction (LVEF) ≥ 50%
  • Premenopausal patients must have a negative serum or urine pregnancy test, including women who have had a tubal ligation and for women less than 12 months after the onset of menopause.
  • Women of childbearing potential and men with partners of childbearing potential must be willing to use one highly effective form of nonhormonal contraception or two effective forms of nonhormonal contraception by the patient and/or partner. Contraceptive use must be continued for the duration of the study treatment and for 7 months after the last dose of study treatment. Hormonal birth control methods are not permitted.
  • Patients should have tumor tissue available, and a tissue block of sufficient size to make 15 slides, which must be sent to DFCI for correlative research. If a tissue block is unavailable, sites may send one H\&E-stained slide and 15 unstained sections of paraffin-embedded tissue on uncharged slides. Slide sections should be 4-5 microns in thickness. It is also acceptable to submit 2 cores from a block of invasive tissue using a 1.2 mm diameter coring tool. If tumor is not available, the investigator must document why tissue is not available in the patient medical record, and that efforts have been made to obtain tissue.
  • Willing and able to sign informed consent
  • Must be able to read and understand English in order to participate in the quality of life surveys. If patient does not read and understand English, the patient is still eligible, but cannot participate in the quality of life surveys.

Who cannot join

  • Any of the following due to teratogenic potential of the study drugs:
  • Pregnant women
  • Nursing women
  • Women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragms, IUDs, surgical sterilization, abstinence, etc.).
  • Men who are unwilling to employ adequate contraception (condoms, surgical sterilization, abstinence, etc.).
  • Locally advanced tumors at diagnosis, including tumors fixed to the chest wall, peau d'orange, skin ulcerations/nodules, or clinical inflammatory changes (diffuse brawny cutaneous induration with an erysipeloid edge)
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  • Patients with a history of previous invasive breast cancer.
  • History of prior chemotherapy in the past 5 years.
  • History of paclitaxel therapy
  • Patients with active liver disease, for example due to hepatitis B virus, hepatitis C virus, autoimmune hepatic disorder, or sclerosing cholangitis
  • Individuals with a history of a different malignancy are ineligible except for the following circumstances:
  • Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy.
  • Individuals with the following cancer are eligible regardless of when they were diagnosed and treated: cervical cancer in situ, and non-melanoma cancer of the skin.
  • Intercurrent illness including, but not limited to: ongoing or active, unresolved systemic infection, renal failure requiring dialysis, active cardiac disease, prior myocardial infarction (asymptomatic changes on EKG suggestive of old MI is not an exclusion), history of CHF, current use of any therapy specifically for CHF, uncontrolled hypertension, significant psychiatric illness, or other conditions that in the opinion of the investigator limit compliance with study requirements.

Trial locations and contacts

53 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Sara Tolaney, MD, MPH contact

617-632-2335

sara_tolaney@dfci.harvard.edu

53 sites in 1 country

United States53 sites, 46 recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Active, not recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

    Sara M. Tolaney, MD MPH, 617-632-2335, Sara_Tolaney@dfci.harvard.edu

    Sara M. Tolaney, MD MPH

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02215

    Laura Spring, MD, 617-724-4000, Lspring2@partners.org

    Laura Spring, MD

    Recruiting

  • Eastern Maine Medical Center (Northern Light)

    Brewer, Maine, 04412

    Laurie Lewis, 207-973-4249, llewis@northernlight.org

    Sarah J Sinclair, DO

    Recruiting

  • Dana-Farber at St. Elizabeth's Medical Center

    Brighton, Massachusetts, 02135

    Wendy Loeser, Wendy_Loeser@DFCI.HARVARD.EDU

    Sara Giordano, MD

    Recruiting

  • New York University Langone Hospital -Brooklyn

    Brooklyn, New York, 11220

    Breast Cancer Center, (718) 630-7000

    Nina D'Abreo, MD

    Recruiting

  • Lahey Clinic

    Burlington, Massachusetts, 01805

    Corrine Zarwan, 781-744-8580, corrine.zarwan@lahey.org

    Amanda Pietras, 781-744-3495, amanda.pietras1@lahey.org

    Recruiting

  • Indiana University Health Joe & Shelly Schwarz Cancer Center

    Carmel, Indiana, 46032

    Active, not recruiting

  • IU Health North Hospital

    Carmel, Indiana, 46032

    Active, not recruiting

  • The University of Chicago Medical Center

    Chicago, Illinois, 60637

    Susan Cohn, MD, 773-702-2571

    Nan Chen, MD

    Recruiting

  • Stefanie Spielman Comprehensive Breast Center

    Columbus, Ohio, 43212

    Breast Cancer Clinical Trials, 800-293-5066

    Gilbert Bader, MD

    Recruiting

  • NH Oncology-Hematology, PA - Payson Center for Cancer Care

    Concord, New Hampshire, 03301

    Ali Fleury, 6032242556, a.fleury@nhoh.com

    Douglas Weckstein, MD

    Recruiting

  • Mass General North Shore Cancer Center

    Danvers, Massachusetts, 01923

    Meegan Petersen, mpetersen1@partners.org

    Katherine Harris, MD

    Recruiting

  • Smilow Cancer Hospital Care center at Derby

    Derby, Connecticut, 06418

    Clinical Trial Offcie Yale Cancer Center, (203) 734-1664

    Daniel O'Neil, MD

    Recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27710

    Active, not recruiting

  • Smilow Cancer Hospital Care center at Fairfield

    Fairfield, Connecticut, 06824

    Clinical Trials Office Yale Cancer Center, (203) 255-2766

    Daniel O'NEIL, MD

    Recruiting

  • Dana-Farber Brigham Cancer Center - Foxborough

    Foxborough, Massachusetts, 02035

    Natalie Sinclair, 781-624-4800, nsinclair1@partners.org

    Natalie Sinclair, MD

    Recruiting

  • Smilow Cancer Hospital Care center at Glastonbury

    Glastonbury, Connecticut, 06033

    Clinical Trial Office Yale Cancer Center, (860) 714-9170

    Daniel O'Neil, MD

    Recruiting

  • Smilow Cancer Hospital Care center at Greenwich

    Greenwich, Connecticut, 06830

    Clinical Trials Office Yale Cancer Center, (203) 863-3700

    Daniel O'Neil, MD

    Recruiting

  • Smilow Cancer Hospital Care center at Guilford

    Guilford, Connecticut, 06437

    Clinical Trial Office Yale Cancer Center, (203) 453-9192

    Daniel O'Neil, MD

    Recruiting

  • Smilow Cancer Hospital Care center at St. Francis

    Hartford, Connecticut, 06105

    Clinical Trial Office Yale Cancer Center, (860) 714-4680

    Daniel O'Neil, MD

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Vicente Valero, MD, 713 563 0751, vvalero@mdanderson.org

    Vicente Valero, MD

    Recruiting

  • Indiana University Melvin and Bren Simon Comprehensive Cancer Center

    Indianapolis, Indiana, 46202

    Active, not recruiting

  • Indiana University Sidney and Lois Eskenazi Hospital

    Indianapolis, Indiana, 46202

    Active, not recruiting

  • Dana-Farber Cancer Insitute at Londonderry Hospital

    Londonderry, New Hampshire, 03053

    Stefani Freeman, RN, StefaniD_Freeman@DFCI.HARVARD.EDU

    Jeanna Walsh, MD

    Recruiting

  • Smilow Cancer Hospital Care center at Long Ridge

    Long Ridge, Connecticut, 06902

    Clinical Trial Office Yale Center, (203) 863-3700

    Daniel O'Neil, MD

    Recruiting

  • Solinsky Center for Cancer Care (NH Oncology-Hematology, PA)

    Manchester, New Hampshire, 03103

    Ali Fleury, 6032242556, a.fleury@nhoh.com

    Douglas Weckstein, MD

    Recruiting

  • Dana-Farber Cancer Instiute - Merrimack Valley

    Methuen, Massachusetts, 01844

    Saida Hussein, saida_hussein@dfci.harvard.edu

    Pedro Sanz-Altamira, MD

    Recruiting

  • Miami Cancer Institute/Baptist Hospital of Miami

    Miami, Florida, 33176

    Reshma Mahtani, DO

    Reshma Mahtani, DO

    Recruiting

  • Dana-Farber at Milford

    Milford, Massachusetts, 01757

    Natalie Sinclair, MD, NSINCLAIR1@PARTNERS.ORG

    Natalie Sinclair, MD

    Recruiting

  • New York University Langone Hospital - Long Island

    Mineola, New York, 11501

    Mehwash "Mahi" Muhammad, mehwash.muhammad@nyulangone.org

    Nina D'Abreo, MD

    Recruiting

  • Greco-Hainsworth Centers for Research/Tennessee Oncology

    Nashville, Tennessee, 37203

    PJ Patterson, 629-294-0801, ppatterson@tnonc.com

    Sara Nunnery, MD

    Recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

    Lisa Simons, Lisa.Simons@scri.com

    Denise Yardley, MD

    Recruiting

  • Yale Cancer Center at Yale University School of Medicine

    New Haven, Connecticut, 06520-8028

    Clinical Trial Office Clinical Trials Office - Yale Cancer Center, 203-785-5702

    Daniel O'Niel, MD

    Recruiting

  • New York University Langone Health

    New York, New York, 10016

    Sylvia Adams, MD, sylvia.adams@nyulangone.org

    Nina D'Abreo, MD

    Recruiting

  • Northwell University

    New York, New York, 10075

    Francisco Esteva, (855)-273-2789, festeva@northwell.edu

    Francisco Esteva

    Recruiting

  • Newton Wellesley Hospital

    Newton, Massachusetts, 02462

    Natassia Mazzola, NAMAZZOLA@mgh.harvard.edu

    Aron Rosenstock, MD

    Recruiting

  • Smilow Cancer Hospital Care center at North Haven

    North Haven, Connecticut, 06510

    Clinical Trials Office Yale Cancer Center, (203) 407-8002

    Daniel O'neil, MD

    Recruiting

  • University of Pennsylvania, Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

    Igor Makhlin, MD, igor.makhlin@pennmedicine.upenn.edu

    Igor Makhlin, MD

    Recruiting

  • University of Pittsburgh Medical Center Cancer UPMC- Magee Women's Hospital

    Pittsburgh, Pennsylvania, 15213

    Marija Balic, 412-647-2811, balicm@upmc.edu

    Rometa Kerney, (412) 641-5430, pollardrr@upmc.edu

    Recruiting

  • Berkshire Medical Center

    Pittsfield, Massachusetts, 01201

    Lori O'Brien, lobrien@bhs1.org

    Thomas Fynan, MD

    Recruiting

  • Miami Cancer Institute - Plantation (MCIP)

    Plantation, Florida, 33324

    Reshma Mahtani, DO, reshma.mahtani@baptisthealth.net

    Reshma Mahtani, DO

    Recruiting

  • New England Cancer Specialists - Portsmouth

    Portsmouth, New Hampshire, 03801

    NECS Research, Research@newecs.org

    Chiara Battelli, MD

    Recruiting

  • Duke Women's Cancer Care Raleigh

    Raleigh, North Carolina, 27710

    Active, not recruiting

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94158

    Hope Rugo, MD

    Hope Rugo, MD

    Recruiting

  • New England Cancer Specialists

    Scarborough, Maine, 04074

    Rachael Farris, research@newecs.org

    Chiara Battelli, MD

    Recruiting

  • Stamford Hospital

    Stamford, Connecticut, 06904

    K.M. Steve Lo, MD, slo@stamhealth.org

    K. M. Steve Lo, MD

    Recruiting

  • Smilow Cancer Hospital Care center at Torrington

    Torrington, Connecticut, 06790

    Clinical Trial Office Yale Cancer Center, (860) 482-5384

    Daniel O'Neil, MD

    Recruiting

  • Smilow Cancer Hospital Care center at Trumbull

    Trumbull, Connecticut, 06611

    Clinical Trials Office Cancer Trial, (203) 502-8400

    Daniel O'Neil, MD

    Recruiting

  • Smilow Cancer Hospital Care center at Waterbury

    Waterbury, Connecticut, 06708

    Clinical Trials Office Yale Cancer Center, (203) 755-6311

    Daniel O'Neil, MD

    Recruiting

  • Smilow Cancer Hospital Care center at Waterford

    Waterford, Connecticut, 06385

    Clinical Trials Office Yale Cancer Center, (860) 444-3744

    Daniel O'Neil, MD

    Recruiting

  • Smilow Cancer Hospital Care center at Westerly

    Westerly, Rhode Island, 02891

    Clinical Trials Office Yale Cancer Center, (401) 656-4950

    Daniel O'Neil, MD

    Recruiting

  • Dana Farber at South Shore Hospital

    Weymouth, Massachusetts, 02190

    Meredith Faggen, meredith_faggen@dfci.harvard.edu

    7816244800

    Recruiting

Other trials in United States

About this study

Official title: A Randomized Phase II Trial of Adjuvant Trastuzumab Emtansine (T-DM1) Followed by Subcutaneous Trastuzumab Versus Paclitaxel in Combination With Subcutaneous Trastuzumab for Stage I HER2-positive Breast Cancer (ATEMPT 2.0)

This research study is studying how well newly diagnosed breast cancer that has tested positive for a protein called HER2 responds using one of two different combination of HER2-directed therapies as a treatment after surgery.

The name of the study drugs involved are:

  • Trastuzumab-emtansine (T-DM1, Kadcyla)
  • Trastuzumab SC (Herceptin Hylecta)
  • Paclitaxel
Read the detailed description

This is a randomized phase II adjuvant study for women and men with Stage I HER2-positive invasive breast cancer. Participants will be randomized into one of two treatment arms in this study and receive:

  • Arm 1: trastuzumab-emtansine (T-DM1, Kadcyla) and trastuzumab SC (Herceptin Hylecta)
  • Arm 2: paclitaxel and trastuzumab SC (Herceptin Hylecta) This research study is looking to see if the study drug T-DM1 followed by trastuzumab SC will have less side-effects than traditional HER2-positive breast cancer treatment of trastuzumab and paclitaxel.The study is also looking to learn about the long-term benefits and disease-free survival of participants who are treated with T-DM1 followed by trastuzumab SC.

T-DM1 is an antibody-drug conjugate; it is made up of an antibody (trastuzumab) linked to a cytotoxic drug, DM1 (chemotherapy). T-DM1 functions as a targeted cancer therapy because it targets HER2-positive breast cancer cells directly, limiting exposure of the rest of the body to chemotherapy. More specifically, the trastuzumab in T-DM1 first binds to the HER2 protein on the surface of the breast cancer cells and the DM1 then enters the cells and can cause them to die, preventing tumor growth. The FDA (the U.S. Food and Drug Administration) has not approved T-DM1 for use on its own in patients with stage I, II, or III breast cancer. However, it has been approved for use in (a) advanced or metastatic, previously treated breast cancer and (b) in some patients receiving postoperative treatment after preoperative chemotherapy and surgery have been completed.

Trastuzumab SC is a subcutaneous form of trastuzumab.Trastuzumab is a monoclonal antibody, which are disease-fighting proteins made by cloned immune cells. Paclitaxel and trastuzumab are considered a standard-of-care regimen in early breast cancer. Trastuzumab is FDA-approved to be administered as an IV (intravenous) or subcutaneous (muscular injection).

The research study procedures include screening for eligibility and study treatment including laboratory evaluations and follow up visits.

Participants will receive study treatment for a year in total and will be followed for 5 years after treatment.

It is expected that about 500 people will take part in this research study.

Genentech is supporting this research study by providing funding for the study and supplying trastuzumab-emtansine (T-DM1) and trastuzumab SC (subcutaneous).

Being tested
trastuzumab-emtansine, Trastuzumab SC, Paclitaxel
Keywords
Breast Cancer, HER2-positive Breast Cancer
Medical subject headings
Breast Neoplasms

What participants receive

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

  • trastuzumab-emtansineDrug

    Also called T-DM1, Kadcyla

    intravenous infusion

  • Trastuzumab SCDrug

    Also called Herceptin Hylecta

    Muscular injection

  • PaclitaxelDrug

    Also called Taxol, Onxal

    intravenous infusion

Study groups in NCT04893109
Study groupRoleWhat they receive
Arm A. T-DM1 followed by Trastuzumab SCExperimentalRandomized participants will receive intravenous T-DM1 every 3 weeks for 6 cycles (18 weeks) and then Trastuzumab SC (subcutaneous) every 3 weeks for 11 cycles
Receives: Drug: trastuzumab-emtansine; Drug: Trastuzumab SC
Arm B: Paclitaxel with Trastuzumab SC, followed by Trastuzumab SC aloneExperimentalRandomized participants will receive weekly intravenous Paclitaxel for 12 weeks (4 cycles) and Trastuzumab SC (subcutaneous) every 3 weeks for 17 cycles. The first 4 doses Trastuzumab SC are given with Paclitaxel.
Receives: Drug: Trastuzumab SC; Drug: Paclitaxel

What is being measured

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

  1. Incidence of clinically relevant toxicities (CRT)

    Compare the incidence of clinically relevant toxicities (CRT) in patients with Stage I HER2-positive breast cancer treated with trastuzumab emtansine followed by trastuzumab SC to the incidence in those treated with paclitaxel in combination with trastuzumab SC as assessed by PRO-CTCAE

    Measured: First 18 weeks of treatment

  2. Disease Free Survival (DFS)

    Evaluate disease-free survival in the T-DM1 followed by trastuzumab SC arm

    Measured: Time from randomization to first Disease Free Survival (DFS) event up to 72 months

Secondary outcomes (14)

  1. Grade 3 and 4 adverse events

    Compare the incidence of all grade 3 and 4 adverse events in patients treated with adjuvant trastuzumab emtansine followed by trastuzumab SC to the incidence in those receiving paclitaxel in combination with trastuzumab SC

    Measured: Enrollment to end of treatment up to 1 year

  2. Quality of Life Assessment: FACT B

    Compare responses to FACT-B quality of life (QOL) questionnaire in patients receiving trastuzumab emtansine followed by trastuzumab SC to that experienced by patients receiving paclitaxel in combination with trastuzumab SC.

    Measured: Enrollment to end of treatment up to 1 year

  3. Symptoms related to therapy

    Evaluate symptoms related to therapy in patients receiving trastuzumab emtansine followed by trastuzumab SC compared to those receiving paclitaxel in combination with trastuzumab SC using the Rotterdam Symptom Checklist (RSCL)

    Measured: Enrollment to end of treatment up to 1 year

  4. Symptoms related to therapy

    Evaluate symptoms related to therapy in patients receiving trastuzumab emtansine followed by trastuzumab SC compared to those receiving paclitaxel in combination with trastuzumab SC using the Patient Neurotoxicity Questionnaire (PNQ)

    Measured: Enrollment to end of treatment up to 1 year

  5. Effects of therapy on work productivity

    Evaluate effects of therapy on work productivity and activity using the Work Productivity and Activity Impairment Questionnaire (WPAI-SHP) in patients receiving trastuzumab emtansine followed by trastuzumab SC compared to those receiving paclitaxel in combination with trastuzumab SC

    Measured: Enrollment to end of treatment up to 1 year

  6. Effect of alopecia on patients

    Evaluate the effects of alopecia on patients receiving paclitaxel in combination with trastuzumab SC using an alopecia questionnaire

    Measured: Enrollment to end of treatment up to 1 year

  7. Incidence of Side Effects

    Compare incidence of sensory neuropathy, headache, arthralgia and myalgia using PRO-CTCAE criteria in patients receiving trastuzumab emtansine followed by trastuzumab SC to that experienced by patients receiving paclitaxel in combination with trastuzumab SC

    Measured: Enrollment to end of treatment up to 1 year

  8. Incidence of grade 3-4 cardiac left ventricular dysfunction

    Evaluate the incidence of grade 3-4 cardiac left ventricular dysfunction in patients treated with adjuvant trastuzumab emtansine followed by trastuzumab SC compared to those receiving paclitaxel with trastuzumab SC

    Measured: Enrollment to end of treatment up to 1 year

  9. Incidence of trastuzumab-emtansine-induced grade 2-4 thrombocytopenia

    Evaluate the incidence of trastuzumab-emtansine-induced grade 2-4 thrombocytopenia

    Measured: Enrollment to end of treatment up to 1 year

  10. Percentage of patients with amenorrhea

    Investigate the percentage of patients with amenorrhea at various time points after the start of treatment in premenopausal women receiving treatment with trastuzumab emtansine followed by trastuzumab SC and paclitaxel with trastuzumab SC

    Measured: Enrollment to end of treatment up to 1 year

  11. Evaluation of gene predictors of trastuzumab-emtansine-induced grade 2-4

    Evaluate gene biomarkers predictive of trastuzumab-emtansine-induced grade 2-4 thrombocytopenia

    Measured: Enrollment to end of treatment up to 1 year

  12. Gene Profiling

    Utilize genomic profiling to query a large panel of cancer gene mutations and gene expression in patients with Stage I HER2-positive breast cancer

    Measured: Enrollment to end of treatment up to 1 year

  13. Radiation therapy Toxicity

    Evaluate the incidence of toxicities attributed to radiation therapy when given concurrently with trastuzumab SC after receipt of either trastuzumab emtansine or paclitaxel

    Measured: Enrollment to end of treatment up to 1 year

  14. Overall survival

    Describe overall survival in patients with Stage I HER2-positive breast cancer treated with trastuzumab emtansine followed by trastuzumab SC

    Measured: Enrollment to end of treatment up to 1 year

Timeline

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

  1. First posted19 May 2021
  2. Study start16 Jun 2021
  3. Primary completion1 Nov 2028 (estimated)
  4. Study completion1 May 2029 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
participants are randomized in a 2-1 fashion to Arm A vs. Arm B
Masking
None (open label)
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04893109
Sponsor's protocol ID
21-159
Status last verified
Aug 2026
First submitted
7 May 2021
Last updated
19 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing trastuzumab-emtansine, Trastuzumab SC and Paclitaxel in people with Breast Cancer and HER2-positive Breast Cancer, run by Dana-Farber Cancer Institute at 53 sites in United States.

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 34 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Contact Sara Tolaney, MD, MPH (617-632-2335, sara_tolaney@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of clinically relevant toxicities (CRT) (time frame: First 18 weeks of treatment). The study lists 2 primary outcomes in all. 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 NCT04893109.

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 19 Aug 2026.

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ATEMPT 2.0: Adjuvant T-DM1 vs TH (NCT04893109) | AzTrials