Can a biopsy predict who will respond to Chemo-Radiation for triple negative breast cancer?
NCT ID NCT02422498
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase II trial is testing whether a pre-treatment biopsy can predict how well patients with locally recurrent or metastatic triple negative breast cancer respond to cisplatin chemotherapy combined with radiation therapy. About 49 participants will receive the treatment, and researchers will compare standard tumor measurements with PET-based response criteria. The goal is to find a better way to personalize treatment for this aggressive cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cisplatin and radiation therapy
- What this could lead to
- If successful, this could help doctors use a biopsy to predict which patients with triple negative breast cancer will benefit from cisplatin and radiation.
- What could go wrong
- This is a small, early-phase trial with only 49 participants, so results may not apply to everyone. The treatment involves chemotherapy and radiation, which can cause side effects.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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49 people
The number who actually took part.
- Started
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Apr 2015
- Expected to finish
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Apr 2028
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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Female participants only
- 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: * Histologically-confirmed invasive triple negative breast cancer (ER \<1%, PR \<1%, her-2-neu 0-1+ by IHC or FISH-negative) or as determined by MD discretion * Radiation to the recurrent or metastatic site is clinically indicated and would be considered standard care for palliation or for locoregional control * Age ≥18 years * Tumor to be irradiated is measurable by RECIST 1.1 or PRC * Willingness to undergo tumor biopsy prior to initiation of treatment * Life expectancy greater than 6 months * ECOG performance status 0-2 * Any prior chemotherapy is allowed including prior treatment with platinum-containing chemotherapy * Prior treatment with FDA-approved or investigational biologics or novel molecularly target therapies, including oral or IV formulations, are permitted. * Patients must be off prior targeted therapy for at least 14 days prior to study biopsy. * Use of an effective means of contraception in women of child-bearing potential * Ability to comprehend and sign informed consent * Adequate organ and marrow function within 14 days prior to study entry, defined as: * Absolute neutrophil count (ANC)\>1000/mm3 * Hemoglobin \>9 gm/dl * Platelets \>100,000/mm3 * Serum creatinine \<1.5 mg/dl OR creatinine clearance of ≥ 50 cc/min * SGOT/SGPT\<2.5X institutional ULN (\<5X ULN if known liver metastases) Exclusion Criteria: * Unmeasurable target tumor site by RECIST 1.1 or PRC (ex: lesions \<2 cm on CT or MR scan, leptomeningeal disease, ascites, pleural/pericardial effusion, lymphangitis, non-FDG-avid skin lesions) * Brain metastases requiring focal or whole brain radiation will be excluded, as these lesions cannot be biopsied and can have life expectancies \<6 months. * Inability to obtain a biopsy of the tumor as deemed by the study Interventional Radiologist * Prior chemotherapy completed \<7 days prior to planned study entry * Prior RT is allowed and must have been completed more than 7 days before planned study entry. * Note: For re-irradiation cases, standard departmental guidelines should be followed so as to not exceed normal tissue * Life expectancy less than 6 months * Intercurrent illness or other major medical condition or comorbid condition that might affect study participation (uncontrolled renal, pulmonary or hepatic dysfunction or infection) * Renal dysfunction for which cisplatin dose would be considered unsafe. * Women on study must be neither pregnant nor nursing nor expected to become pregnant during therapy. For premenopausal women, negative pregnancy test within 14 days of RT is required. * Concurrent active malignancy other than non-melanomatous skin cancer or carcinoma in-situ of the cervix, unless treatment for the previous cancer was completed \>2 years prior to study entry and patient has remained disease-free.
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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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Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, 11725, United States
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Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
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Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
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Memorial Sloan Kettering at Basking Ridge
Basking Ridge, New Jersey, 07920, United States