Could less chemo be enough for some breast cancer patients?
NCT ID NCT03716180
First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This pilot study is testing whether women with HER2-positive breast cancer who respond well to initial chemotherapy can safely receive less treatment after surgery. About 100 participants will receive a combination of drugs (paclitaxel, trastuzumab, and pertuzumab) before surgery, and those whose tumors disappear completely will only get antibody therapy afterward. The goal is to see if this de-escalated approach is acceptable to patients and doctors, while still controlling the disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Paclitaxel, Trastuzumab, and Pertuzumab
- What this could lead to
- If successful, this could show that some patients with HER2-positive breast cancer can safely receive less chemotherapy after surgery, reducing side effects.
- What could go wrong
- This is a small, early-phase pilot study, so results may not apply to all patients. The approach may not work for everyone, and there is a risk of cancer recurrence with reduced treatment.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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100 people
The number who actually took part.
- Started
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Nov 2018
- Expected to finish
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Sep 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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 Stage II or III (according to AJCC cancer staging manual anatomic staging table, 8th edition) histologically confirmed invasive carcinoma of the breast. A minimum tumor size of 1.5 cm determined by physical exam or imaging (whichever is larger) is required. Patients with inflammatory breast carcinoma (T4d) are NOT eligible. * Tumors must be HER-2 positive, as assessed by standard local institutional protocol (central testing is not required): * IHC 3+ * FISH positive based on one of the three following criteria: Single-probe average HER2 copy number ≥ 6.0 signals/cell; OR * Dual-probe HER2/CEP17 ratio \<2.0 with an average HER2 copy number ≥ 6.0 signals/cell; OR * Dual-probe HER2/CEP17 ratio ≥2.0 * 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 are allowed as long as both cancers are HER2-positive (as defined in 3.1.2), or the contralateral cancer is a \<1 cm, ER+, and HER2- tumor. * Patients with multifocal or multicentric disease are eligible as long as all tumor foci that were tested for HER2 status at the local institution are HER2-positive, and at least one tumor focus meets eligibility criteria. * Breast imaging should include dedicated ultrasound of the ipsilateral axilla. For subjects with a clinically positive axilla based on exam or imaging, a fine needle aspiration or core biopsy procedure will be performed to determine the presence of metastatic disease in the lymph nodes (though lymph node sampling procedure need not be resulted prior to patient's registration on trial, as long as all other eligibility are met). * Men and women (with any menopausal status) ≥ 18 years of age are eligible. * ECOG PS 0 or 1. * Required laboratory values: * ANC ≥ 1000/mm3 * Hemoglobin ≥ 9 g/dl * Platelets ≥ 100,000/mm3 * Serum creatinine \< 1.5 x ULN (institutional) OR calculated GFR ≥60mL/min. -Total bilirubin ≤ 1.5 x ULN (institutional). For patients with Gilbert Syndrome, the direct bilirubin should be within the institutional normal range OR total bilirubin ≤ 2.0 mg/dL. * AST and ALT ≤ 2.5x ULN (institutional) * Left ventricular ejection fraction (LVEF) ≥ 50%. * Premenopausal women must have a negative serum pregnancy test within 14 days of registration, 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 non-hormonal contraception or two effective forms of non-hormonal contraception by the patient and/or partner and continue its use for the duration of the study treatment and for 7 months after the last dose of study treatment. * Patients with a history of ipsilateral DCIS are eligible. * Patients undergoing breast conservation therapy (i.e. lumpectomy) must not have any contraindications to radiation therapy. * Willing and able to sign informed consent. * Willing to provide tissue for research purposes Exclusion Criteria: * Pregnant or nursing women due to the teratogenic potential of the study drugs. * Active, unresolved infection. * Receipt of intravenous antibiotics for infection within 7 days prior to registration. * Uncontrolled hypertension (systolic \>180 mm Hg and/or diastolic \>100 mm Hg) or clinically significant (i.e. active) cardiovascular disease: cerebrovascular accident/stroke or myocardial infarction within 6 months prior to first study medication, unstable angina, congestive heart failure (CHF) of New York Heart Association (NYHA) Class II or higher (see Appendix B), or serious cardiac arrhythmia requiring medication. * Significant symptoms (Grade ≥ 2) from peripheral neuropathy. * Other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness, uncontrolled infections, uncontrolled diabetes. * Any prior treatment for the current breast cancer, including chemotherapy, hormonal therapy, radiation, or experimental therapy
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
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DF/BWCC at Milford Regional Medical Center
Milford, Massachusetts, 01757, United States
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DF/BWCC in clinical affiliation with South Shore Hospital
South Weymouth, Massachusetts, 02190, United States
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Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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