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AzTrials

Invasive Breast CancerPhase 3NCT00486668

A Study of AC Followed by a Combination of Paclitaxel Plus Trastuzumab or Lapatinib or Both Given Before Surgery to Patients With Operable HER2 Positive Invasive Breast Cancer

A Phase 3 study testing doxorubicin, cyclophosphamide and paclitaxel in people with Invasive Breast Cancer, run by NSABP Foundation Inc at 110 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The primary purpose of this study is to determine whether breast cancer tumors respond (as measured by pathologic complete response: the absence of microscopic evidence of invasive tumor cells in the breast) to combined chemotherapy of AC(doxorubicin and cyclophosphamide) followed by paclitaxel plus trastuzumab or… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Invasive Breast Cancer
What is being tested?
doxorubicin, cyclophosphamide and paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
529 participants
Where
110 sitesin 3 countries
Study dates
Jul 2007to Mar 2017
Phase
Phase 3
Are there results?
None posted in the registry

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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female
  • 18 years or older
  • ECOG performance status of 0 or 1
  • Primary breast tumor palpable and measures greater than or equal to 2.0 cm by physical exam
  • Diagnosis of invasive adenocarcinoma made by core needle biopsy
  • Breast cancer determined to be HER2-positive
Show all 19Show fewer
  • LVEF assessment by MUGA scan or ECG within 3 months prior to randomization
  • Blood counts must meet the following criteria:
  • ANC greater than or equal to 1200/mm3
  • Platelet count greater than or equal to 100,000/mm3
  • Hemoglobin greater than or equal to 10 g/dL
  • Serum creatinine less than or equal to ULN for the lab
  • Adequate hepatic function by these criteria:
  • Total bilirubin less than or equal to the ULN for the lab unless the patient has a bilirubin elevation greater than ULN to 1.5 x ULN resulting from Gilbert's disease or similar syndrome due to slow conjugation of bilirubin; and
  • Alkaline phosphatase less than or equal to 2.5 x ULN; and
  • AST less than or equal to 1.5 x ULN for the lab.
  • If skeletal pain present or alkaline phosphatase greater than ULN (but less than or equal to 2.5 x ULN), bone scan or PET scan must not demonstrate metastatic disease
  • If AST or alkaline phosphatase greater than ULN , liver imaging (CT, MRI or PET scan) must not demonstrate definitive metastatic disease and the requirements in criterion for hepatic function must be met
  • Able to swallow oral medications

Who cannot join

  • FNA alone to diagnose the primary tumor
  • Excisional biopsy or lumpectomy was performed prior to randomization
  • Surgical axillary staging procedure prior to randomization. Exceptions: 1) FNA or core biopsy of an axillary node for any patient, and 2) although not recommended, a pre-neoadjuvant therapy SN biopsy for patients with clinically negative axillary nodes.
  • Tumors clinically staged as T4
  • Ipsilateral cN2b or cN3 disease (Patients with cN1 or cN2a disease are eligible)
  • Definitive clinical or radiologic evidence of metastatic disease
Show all 33Show fewer
  • Synchronous bilateral invasive breast cancer
  • Requirement for chronic use of any of the medications or substances specified in the protocol
  • Treatment including RT, chemotherapy, and/or targeted therapy for the currently diagnosed breast cancer prior to randomization
  • Any sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy, etc. (These patients are eligible if therapy is discontinued prior to randomization)
  • Continued therapy with any hormonal agent such as raloxifene, tamoxifen, or other SERM. (Patients are eligible only if these medications are discontinued prior to randomization)
  • Prior history of breast cancer, including DCIS (Patients with a history of LCIS are eligible)
  • Prior therapy with anthracyclines, taxanes, trastuzumab, or lapatinib for any malignancy
  • Other malignancies unless the patient is considered to be disease-free for 5 or more years prior to randomization and is deemed by her physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.
  • Cardiac disease that would preclude the use of the drugs included in the B-41 treatment regimens. This includes but is not confined to:
  • Active cardiac disease:
  • angina pectoris requiring the use of anti-anginal medication;
  • ventricular arrhythmias except for benign premature ventricular contractions controlled by medication;
  • conduction abnormality requiring a pacemaker;
  • supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; and
  • clinically significant valvular disease.
  • History of cardiac disease:
  • myocardial infarction;
  • congestive heart failure; or
  • cardiomyopathy.
  • Uncontrolled hypertension, defined as blood pressure greater than 150/90 mm/Hg on antihypertensive therapy
  • History of or current symptomatic interstitial pneumonitis or pulmonary fibrosis or definitive evidence of interstitial pneumonitis or pulmonary fibrosis described on CT or chest x-ray in asymptomatic patients
  • Sensory/motor neuropathy greater than or equal to grade 2, as defined by the NCI's CTCAE v3.0
  • Malabsorption syndrome, ulcerative colitis, resection of the stomach or small bowel, or other disease significantly affecting gastrointestinal function
  • Other non-malignant systemic disease that would preclude treatment with any of the treatment regimens or would prevent required follow-up
  • Conditions that would prohibit administration of corticosteroids
  • Administration of any investigational agents within 30 days before randomization
  • Pregnancy or lactation

Trial locations and contacts

110 sites in 3 countries.

110 sites in 3 countries

United States103 sites

  • Akron City Hospital

    Akron, Ohio, 44304

  • Phoebe Putney Memorial Hospital

    Albany, Georgia, 31701

  • New York Oncology Hematology PC-Albany

    Albany, New York, 12206

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18105

  • CCOP, Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • MBCCOP, Medical College of Georgia Research Institute

    Augusta, Georgia, 30912

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • Franklin Square Hospital Center

    Baltimore, Maryland, 21237

  • CCOP, Montana Cancer Consortium

    Billings, Montana, 59101

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Alamance Regional Medical Center

    Burlington, North Carolina, 27215

  • Aultman Hospital

    Canton, Ohio, 44710

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 28302

  • CCOP, Southeast Cancer Control Consortium

    Charlotte, North Carolina, 28203

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Case Western Reserve/University Hospitals-Ireland Cancer Cntr.

    Cleveland, Ohio, 44106

  • Kootenai Cancer Center

    Coeur d'Alene, Idaho, 83814

  • Memorial Hospital

    Colorado Springs, Colorado, 80909

  • University of Missouri-Ellis Fischel

    Columbia, Missouri, 65203

  • Ohio State University

    Columbus, Ohio, 43017

  • CCOP, Columbus, OH

    Columbus, Ohio, 43215

  • Geisinger Clinic

    Danville, Pennsylvania, 17882-2170

  • CCOP, Dayton, OH

    Dayton, Ohio, 45429

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Kaiser Permanente-Franklin

    Denver, Colorado, 80205

  • CCOP-Colorado Cancer Research Prog. Inc.(Administrative Only)

    Denver, Colorado, 80224

  • CCOP, Des Moines, IA

    Des Moines, Iowa, 52501

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Cancer Institute at Alexian Brothers Hospital Network

    Elk Grove, Illinois, 60007

  • Cancer Center at Glens Falls Hospital

    Glens Falls, New York, 12801

  • CCOP, Grand Rapids Clnical Oncology Program

    Grand Rapids, Michigan, 49503

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • University of Hawaii

    Honolulu, Hawaii, 96813

  • Kaiser Permanente Hawaii - Moanalua Med Center

    Honolulu, Hawaii, 96819

  • St. Vincent Hospital and Health Care Center

    Indianapolis, Indiana, 46260

  • University of Iowa

    Iowa City, Iowa, 52242

  • CCOP, Kalamazoo, MI

    Kalamazoo, Michigan, 49007

  • CCOP, Kansas City (Administrative Only)

    Kansas City, Missouri, 64131

  • Thompson Cancer Survival Center-Dowell Springs

    Knoxville, Tennessee, 37909

  • Scripps Cancer Center-San Diego

    La Jolla, California, 92037

  • Kaiser Permanente Rock Creek

    Lafayette, Colorado, 80026

  • Michigan State University - Breslin Cancer Center

    Lansing, Michigan, 48910

  • University of Kentucky Medical Center

    Lexington, Kentucky, 40536

  • University of California, Irvine Medical Center

    Long Beach, California, 90801

  • Pacific Shores Medical Group

    Long Beach, California, 90813

  • NortonHealtcare Inc.

    Louisville, Kentucky, 40202

  • Joe Arrington Cancer Research & Treatment Center

    Lubbock, Texas, 79410

  • CCOP, Marshfield Clinic

    Marshfield, Wisconsin, 54449

  • Alamance Regional Medical Center - Off site Clinic

    Mebane, North Carolina, 27302

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • CCOP, Metro-Minnesota

    Minneapolis, Minnesota, 55416

  • MBCCOP, Gulf Coast

    Mobile, Alabama, 36608

  • West Virginia University Hospitals Inc.

    Morgantown, West Virginia, 26506-9162

  • Edward Hospital

    Naperville, Illinois, 60566

  • Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

  • CCOP, Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • Eastern Connecticut Hematology & Oncology Associates

    Norwich, Connecticut, 06360

  • CCOP, Missouri Valley Consortium

    Omaha, Nebraska, 74136

  • St. Joseph Hospital

    Orange, California, 92868

  • MD Anderson Cancer Center

    Orlando, Florida, 32806

  • Desert Regional Medical Center Comprehensive Cancer Center

    Palm Springs, California, 92262

  • Stanford University Medical Center

    Palo Alto, California, 94304

  • Camden-Clark Memorial Hospital

    Parkersburg, West Virginia, 26101

  • Albert Einstein Healthcare Network

    Philadelphia, Pennsylvania, 19141-3098

  • Allegheny General Hospital/Allegheny-Singer Research Institute

    Pittsburgh, Pennsylvania, 15212

  • NSABP Foundation, Inc.

    Pittsburgh, Pennsylvania, 15212

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224

  • Edward Cancer Center Plainfield

    Plainfield, Illinois, 60585

  • MBCCOP, Virginia Commonwealth University

    Richmond, Virginia, 23298

  • CCOP, William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • Sutter Medical Center

    Sacramento, California, 95816

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • Kaiser Permanente-San Diego

    San Diego, California, 92120

  • Santa Rosa Memorial Hospital

    Santa Rosa, California, 95403

  • Mercy Hospital

    Scranton, Pennsylvania, 18501

  • Puget Sound Oncology Consortium

    Seattle, Washington, 98109

  • CCOP, Virginia Mason

    Seattle, Washington, 99519

  • CCOP, Sioux Community Cancer consortium

    Sioux City, Iowa, 51101

  • Sanford Cancer Center

    Souix Falls, South Dakota, 57104

  • CCOP, Northern Indiana Cancer Research Consortium

    South Bend, Indiana, 46601

  • Providence Hospital - Southfield

    Southfield, Michigan, 48075-9975

  • CCOP, Upstate Carolina

    Spartanburg, South Carolina, 29303

  • CCOP, Central Illinois

    Springfield, Illinois, 62526

  • CCOP, Ozark Health Ventures LLC

    Springfield, Missouri, 65804

  • Saint Louis UniversityHealth Sciences Center

    St Louis, Missouri, 63110

  • CCOP, Heartland Cancer Research

    St Louis, Missouri, 63131

  • CCOP, Hematology-Oncology Associates of CNY

    Syracuse, New York, 13057

  • CCOP, Northwest

    Tacoma, Washington, 83706

  • CCOP, Oklahoma

    Tulsa, Oklahoma, 74136

  • CCOP, Carle Cancer Center

    Urbana, Illinois, 61801

  • Kaiser Permanente-Vallejo

    Vallejo, California, 94589

  • Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016

  • Reading Hospital & Medical Center

    West Reading, Pennsylvania, 19612

  • Wheeling Hospital

    Wheeling, West Virginia, 26003

  • CCOP, Wichita KS

    Wichita, Kansas, 67214

  • Wake Forest University School of Medicine

    Winston-Salem, North Carolina, 27157

  • CCOP, Main Line Health

    Wynnewood, Pennsylvania, 19096

Other trials in United States

Canada6 sites

  • Royal Victoria Hospital

    Montreal, Quebec, H3A 1A1

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • St. Mary's Hospital Center

    Montreal, Quebec, H3T 1M5

  • University of Montreal Hospital Group

    Montreal, Quebec

  • Centre Hospitalier Affilie Universitaire De Quebec, Hospital du St-Sacrement

    Québec, Quebec, G1S 4L8

  • Odette Cancer Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

Puerto Rico1 site

  • MBCCOP, San Juan, Puerto Rico

    San Juan, 00936

Other trials in Puerto Rico

About this study

Official title: A Randomized Phase III Trial of Neoadjuvant Therapy for Patients With Palpable and Operable HER2-Positive Breast Cancer Comparing the Combination of Trastuzumab Plus Lapatinib to Trastuzumab and to Lapatinib Administered With Weekly Paclitaxel Following AC Accompanied by Correlative Science Studies to Identify Predictors of Pathologic Complete Response

The primary purpose of this study is to determine whether breast cancer tumors respond (as measured by pathologic complete response: the absence of microscopic evidence of invasive tumor cells in the breast) to combined chemotherapy of AC(doxorubicin and cyclophosphamide) followed by paclitaxel plus trastuzumab or lapatinib or both given before surgery to patients with HER2-positive breast cancer. Trastuzumab will also be given to all patients after surgery. The study will also evaluate the toxic effects of the chemotherapy combination, including effects on the heart, and will determine survival and progression-free survival 5 years after treatment. Also, the study will look at whether there are gene expression profiles in the tumor tissue that can predict pathologic complete response.

Read the detailed description

Women with breast cancers that overexpress HER2 are at greater risk for disease progression and death than women whose tumors do not overexpress HER2. Trastuzumab, a recombinant humanized monoclonal antibody against the extracellular domain of the HER2 protein blocks downstream signaling of HER2 and substantially improves the efficacy of chemotherapy in women with metastatic and early-stage HER2-positive breast cancers. Because resistance to trastuzumab eventually results in progressive disease in the metastatic setting and contributes to recurrence following adjuvant trastuzumab-based therapy, it is important to develop agents other than trastuzumab that target HER2 signaling through different mechanisms of action. Lapatinib is an oral, small molecule, dual tyrosine kinase inhibitor of HER2 and EGFR. Lapatinib has shown a lack of cross-resistance with trastuzumab in preclinical studies and activity in women with HER2-positive, metastatic breast cancer that has progressed during trastuzumab treatment. Trastuzumab blocks the downstream signaling of HER2 by binding to the extracellular domain of the receptor. Lapatinib binds to the intracellular domains of HER2 and EGFR and prevents activation of downstream signaling pathways. Because of this different mechanism of action, lapatinib may be effective in trastuzumab-resistant disease. The study will also provide important safety information on trastuzumab and lapatinib combinations immediately following anthracycline exposure, and also provide an initial direct comparison of cardiac effects of trastuzumab and lapatinib when incorporated into a standard sequential AC followed by weekly paclitaxel (neo)adjuvant regimen.

Availability of a second agent that can interrupt HER2-signaling pathways through completely different mechanisms than those of trastuzumab offers the potential for further improvement in the management of patients with HER2-overexpressing breast cancer in both the adjuvant and metastatic setting. Co-administration of both trastuzumab and lapatinib with chemotherapy may be important in improving outcomes in subsets of HER2-positive breast cancers. However, use of two inhibitors of the HER2 pathway will increase costs and may increase toxicity, so it will be important to identify the subsets of patients who would benefit from the dual therapy. Inhibition of HER2 with a single agent clearly is sufficient for many patients as evidenced by the results of the trastuzumab trials. Therefore, co-administration to unselected populations of women with HER2-positive breast cancers would not represent an optimal approach. Given the activity of lapatinib, it is likely that it will also be sufficiently active in inhibiting HER2-pathway activation in some patients to allow for its use as the sole inhibitor of the HER2 pathway. Different populations may also derive greater benefit from one of the HER2-blocking agents relative to the other. Identification of potential predictive factors for pathologic complete response to the combination or to either agent administered alone in neoadjuvant trials would provide important information for adjuvant trials designed to definitively address these important issues.

This study will compare 3 combined chemotherapy regimens: AC followed by paclitaxel plus trastuzumab and lapatinib, AC followed by paclitaxel plus lapatinib, and AC followed by paclitaxel plus trastuzumab given before surgery to patients with HER2-positive breast cancer.

Keywords
HER2 positive breast cancer, invasive breast cancer, lapatinib, neoadjuvant, NSABP, paclitaxel, trastuzumab, doxorubicin, cyclophosphamide

What participants receive

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

  • doxorubicinDrug

    60 mg/m2 IV every 21 days for cycles 1-4

  • cyclophosphamideDrug

    600 mg/m2 IV every 21 days for cycles 1-4

  • paclitaxelDrug

    80 mg/m2 IV on days 1, 8, and 15 every 28 days for cycles 5-8

  • trastuzumabDrug

    First dose: 4 mg/kg IV, subsequent doses: 2 mg/kg IV weekly beginning on day 1 of the first paclitaxel cycle until 1-7 days before surgery

  • lapatinibDrug

    Group 2: 1250 mg PO daily beginning on day 1 of the first paclitaxel cycle until 1 day before surgery. Group 3: 750 mg PO daily beginning on day 1 of the first paclitaxel cycle until 1 day before surgery.

Study groups in NCT00486668
Study groupRoleWhat they receive
Group 1: AC then paclitaxel + trastuzumabActive comparatorAC followed by paclitaxel plus trastuzumab
Receives: Drug: doxorubicin; Drug: cyclophosphamide; Drug: paclitaxel; Drug: trastuzumab
Group 2: AC then paclitaxel + lapatinibExperimentalAC followed by paclitaxel plus lapatinib
Receives: Drug: doxorubicin; Drug: cyclophosphamide; Drug: paclitaxel; Drug: lapatinib
Group 3: AC then paclitaxel + trastuzumab + lapatinibExperimentalAC followed by paclitaxel plus trastuzumab plus lapatinib
Receives: Drug: doxorubicin; Drug: cyclophosphamide; Drug: paclitaxel; Drug: trastuzumab; Drug: lapatinib

What is being measured

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

  1. Determination of pathologic complete response (pCR), defined by the absence of microscopic evidence of invasive tumor cells in the post chemotherapy surgical breast specimen.

    Measured: surgery following chemotherapy

Secondary outcomes (7)

  1. The determination of pCR in the surgical breast and lymph node specimens following chemotherapy.

    Measured: surgery following chemotherapy

  2. Clinical tumor measurement as assessed by physical exam of the breast and lymph nodes

    Measured: baseline (prior to starting protocol therapy), at the completion of AC (before starting paclitaxel and trastuzumab and/or lapatinib), and at the conclusion of the sequential regimens (prior to surgery).

  3. Determination of cardiac toxicity as measured by the incidence of cardiac events defined as definite or probable cardiac death

    Measured: two year cumulative incidence

  4. Determination of non-cardiac toxicities as measured by frequencies of adverse events categorized using CTCAE v3.0.

    Measured: through 5 years after entry

  5. Overall survival as measured by time from randomization until death from any cause.

    Measured: through 5 years after entry

  6. Recurrence-free interval as measured by occurrence of inoperable progressive disease, or from time of surgery to occurrence of local, regional, or distant recurrence in patients with operable disease.

    Measured: through 5 years after entry

  7. In tumor tissue, a comparison of array comparative genomic hybridization (CGH) data with gene expression profile data to examine coordinated overexpression of amplified genes, especially in HER2 and cMYC loci.

    Measured: Tissue sample collected at surgery following chemotherapy

Timeline

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

  1. First posted15 Jun 2007 (estimated)
  2. Study startJul 2007
  3. Primary completionJun 2012
  4. Study completionMar 2017 (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
None (open label)
Enrolment
529 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00486668
Sponsor's protocol ID
NSABP B-41
Status last verified
Jun 2016
First submitted
13 Jun 2007
Last updated
6 Jun 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Robidoux A, Tang G, Rastogi P, Geyer CE Jr, Azar CA, Atkins JN, Fehrenbacher L, Bear HD, Baez-Diaz L, Sarwar S, Margolese RG, Farrar WB, Brufsky AM, Shibata HR, Bandos H, Paik S, Costantino JP, Swain SM, Mamounas EP, Wolmark N. Lapatinib as a component of neoadjuvant therapy for HER2-positive operable breast cancer (NSABP protocol B-41): an open-label, randomised phase 3 trial. Lancet Oncol. 2013 Nov;14(12):1183-92. doi: 10.1016/S1470-2045(13)70411-X. Epub 2013 Oct 4.

    PubMed 24095300

  • Rastogi P, Tang G, Hassan S, Geyer CE Jr, Azar CA, Magrinat GC, Suga JM, Bear HD, Baez-Diaz L, Sarwar S, Boileau JF, Brufsky AM, Shibata HR, Bandos H, Paik S, Yothers G, Swain SM, Mamounas EP, Wolmark N. Long-term outcomes of dual vs single HER2-directed neoadjuvant therapy in NSABP B-41. Breast Cancer Res Treat. 2023 Jun;199(2):243-252. doi: 10.1007/s10549-023-06881-8. Epub 2023 Mar 22.

    PubMed 36944848

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing doxorubicin, cyclophosphamide and paclitaxel in people with Invasive Breast Cancer, run by NSABP Foundation Inc at 110 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 19 inclusion and 33 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: status not confirmed, as of the sponsor's last update on 6 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 110 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?

Results are not available in the source record.

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?

Determination of pathologic complete response (pCR), defined by the absence of microscopic evidence of invasive tumor cells in the post chemotherapy surgical breast specimen. (time frame: surgery following chemotherapy). 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 NCT00486668, 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 6 Jun 2016.

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