New trial aims to find safer treatment for early HER2 breast cancer

NCT ID NCT04893109

Disease control Sponsor: Dana-Farber Cancer Institute Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 20, 2026 · Updated 4 times

Summary

This phase 2 trial is testing two different drug combinations for people with stage I HER2-positive breast cancer after surgery. One group gets trastuzumab emtansine (T-DM1) followed by trastuzumab injections, while the other gets paclitaxel plus trastuzumab. The goal is to see which approach causes fewer serious side effects and better prevents the cancer from coming back. About 500 participants will be enrolled.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: trastuzumab emtansine (T-DM1), trastuzumab SC, and paclitaxel
What this could lead to: If successful, this study could identify a safer and more effective treatment option for early-stage HER2-positive breast cancer, reducing side effects while maintaining disease control.
What could go wrong: This is a phase 2 trial with 500 participants, so results are preliminary. The treatments may cause significant side effects, and the study may not show a clear benefit for one approach over the other.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2021

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 * 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. Exclusion Criteria: * 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) * 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.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm HER2 positive breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer HER2-positive breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

The study's own enquiry address

This study publishes an address for enquiries. See it below .
The places running it

46 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Show contact details

Locations

Berkshire Medical Center
RECRUITING

Pittsfield, Massachusetts, 01201, United States
Beth Israel Deaconess Medical Center
ACTIVE_NOT_RECRUITING

Boston, Massachusetts, 02215, United States
Dana Farber Cancer Institute
RECRUITING

Boston, Massachusetts, 02215, United States
Dana Farber at South Shore Hospital
RECRUITING

Weymouth, Massachusetts, 02190, United States
Dana-Farber Brigham Cancer Center - Foxborough
RECRUITING

Foxborough, Massachusetts, 02035, United States
Dana-Farber Cancer Insitute at Londonderry Hospital
RECRUITING

Londonderry, New Hampshire, 03053, United States
Dana-Farber Cancer Instiute - Merrimack Valley
RECRUITING

Methuen, Massachusetts, 01844, United States
Dana-Farber at Milford
RECRUITING

Milford, Massachusetts, 01757, United States
Dana-Farber at St. Elizabeth's Medical Center
RECRUITING

Brighton, Massachusetts, 02135, United States
Duke University Medical Center
ACTIVE_NOT_RECRUITING

Durham, North Carolina, 27710, United States
Duke Women's Cancer Care Raleigh
ACTIVE_NOT_RECRUITING

Raleigh, North Carolina, 27710, United States
Eastern Maine Medical Center (Northern Light)
RECRUITING

Brewer, Maine, 04412, United States
Greco-Hainsworth Centers for Research/Tennessee Oncology
RECRUITING

Nashville, Tennessee, 37203, United States
IU Health North Hospital
ACTIVE_NOT_RECRUITING

Carmel, Indiana, 46032, United States
Indiana University Health Joe & Shelly Schwarz Cancer Center
ACTIVE_NOT_RECRUITING

Carmel, Indiana, 46032, United States
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
ACTIVE_NOT_RECRUITING

Indianapolis, Indiana, 46202, United States
Indiana University Sidney and Lois Eskenazi Hospital
ACTIVE_NOT_RECRUITING

Indianapolis, Indiana, 46202, United States
Lahey Clinic
RECRUITING

Burlington, Massachusetts, 01805, United States
MD Anderson Cancer Center
RECRUITING

Houston, Texas, 77030, United States
Mass General North Shore Cancer Center
RECRUITING

Danvers, Massachusetts, 01923, United States
Massachusetts General Hospital
RECRUITING

Boston, Massachusetts, 02215, United States
Miami Cancer Institute - Plantation (MCIP)
RECRUITING

Plantation, Florida, 33324, United States
Miami Cancer Institute/Baptist Hospital of Miami
RECRUITING

Miami, Florida, 33176, United States
NH Oncology-Hematology, PA - Payson Center for Cancer Care
RECRUITING

Concord, New Hampshire, 03301, United States
New England Cancer Specialists
RECRUITING

Scarborough, Maine, 04074, United States

Contact Email: •••••@•••••
New England Cancer Specialists - Portsmouth
RECRUITING

Portsmouth, New Hampshire, 03801, United States
New York University Langone Health
RECRUITING

New York, New York, 10016, United States
New York University Langone Hospital - Long Island
RECRUITING

Mineola, New York, 11501, United States
New York University Langone Hospital -Brooklyn
RECRUITING

Brooklyn, New York, 11220, United States
Newton Wellesley Hospital
RECRUITING

Newton, Massachusetts, 02462, United States
Northwell University
RECRUITING

New York, New York, 10075, United States
SCRI Oncology Partners
RECRUITING

Nashville, Tennessee, 37203, United States
Smilow Cancer Hospital Care center at Derby
RECRUITING

Derby, Connecticut, 06418, United States
Smilow Cancer Hospital Care center at Fairfield
RECRUITING

Fairfield, Connecticut, 06824, United States
Smilow Cancer Hospital Care center at Glastonbury
RECRUITING

Glastonbury, Connecticut, 06033, United States
Smilow Cancer Hospital Care center at Greenwich
RECRUITING

Greenwich, Connecticut, 06830, United States
Smilow Cancer Hospital Care center at Guilford
RECRUITING

Guilford, Connecticut, 06437, United States
Smilow Cancer Hospital Care center at Long Ridge
RECRUITING

Long Ridge, Connecticut, 06902, United States
Smilow Cancer Hospital Care center at North Haven
RECRUITING

North Haven, Connecticut, 06510, United States
Smilow Cancer Hospital Care center at St. Francis
RECRUITING

Hartford, Connecticut, 06105, United States
Smilow Cancer Hospital Care center at Torrington
RECRUITING

Torrington, Connecticut, 06790, United States
Smilow Cancer Hospital Care center at Trumbull
RECRUITING

Trumbull, Connecticut, 06611, United States
Smilow Cancer Hospital Care center at Waterbury
RECRUITING

Waterbury, Connecticut, 06708, United States
Smilow Cancer Hospital Care center at Waterford
RECRUITING

Waterford, Connecticut, 06385, United States
Smilow Cancer Hospital Care center at Westerly
RECRUITING

Westerly, Rhode Island, 02891, United States
Solinsky Center for Cancer Care (NH Oncology-Hematology, PA)
RECRUITING

Manchester, New Hampshire, 03103, United States
Stamford Hospital
RECRUITING

Stamford, Connecticut, 06904, United States
Stefanie Spielman Comprehensive Breast Center
RECRUITING

Columbus, Ohio, 43212, United States
The University of Chicago Medical Center
RECRUITING

Chicago, Illinois, 60637, United States
UCSF Helen Diller Family Comprehensive Cancer Center
RECRUITING

San Francisco, California, 94158, United States
University of Pennsylvania, Abramson Cancer Center
RECRUITING

Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Medical Center Cancer UPMC- Magee Women's Hospital
RECRUITING

Pittsburgh, Pennsylvania, 15213, United States
Yale Cancer Center at Yale University School of Medicine
RECRUITING

New Haven, Connecticut, 06520-8028, United States

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