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Can a biopsy predict who will respond to Chemo-Radiation for triple negative breast cancer?

NCT ID NCT02422498

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

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

Participants

49 people

The number who actually took part.

Started

Apr 2015

Expected to finish

Apr 2028

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

Female participants only

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: * 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

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Cancer Center @ Suffolk

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604, United States

  • Memorial Sloan Kettering at Basking Ridge

    Basking Ridge, New Jersey, 07920, United States