Locally Recurrent/Metastatic Triple Negative Breast CancerPhase 2NCT02422498
Homologous Recombination Repair Status as a Biomarker of Response in Locally Recurrent/Metastatic Triple Negative Breast Cancer Patients Treated With Concurrent Cisplatin and Radiation Therapy
A Phase 2 study testing external beam radiation therapy, cisplatin and Biopsy of Target Tumor in people with Locally Recurrent/Metastatic Triple Negative Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
The study is being done to find out if the results of a pre-treatment biopsy can predict response to cisplatin and radiation treatment for patients with metastatic or recurrent triple negative breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Locally Recurrent/Metastatic Triple Negative Breast Cancer
- What is being tested?
- external beam radiation therapy, cisplatin and Biopsy of Target Tumor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 7 sitesUnited States
- Study dates
- 14 Apr 2015to 14 Apr 2028
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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
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- 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)
Who cannot join
- 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
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- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Memorial Sloan Kettering at Basking Ridge
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
About this study
Official title: A Phase II Trial of Homologous Recombination Repair Status as a Biomarker of Response in Locally Recurrent/Metastatic Triple Negative Breast Cancer Patients Treated With Concurrent Cisplatin and Radiation Therapy
The study is being done to find out if the results of a pre-treatment biopsy can predict response to cisplatin and radiation treatment for patients with metastatic or recurrent triple negative breast cancer.
- Being tested
- external beam radiation therapy, cisplatin, Biopsy of Target Tumor
- Keywords
- Treated with Concurrent Cisplatin, Treated with Radiation Therapy, Homologous Recombination Repair Status, Biomarker of Response, 15-032, Patients
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
external beam radiation therapyRadiation
Radiation therapy to the target tumor will be delivered with external beam radiation therapy. In metastatic cases where the intent is palliative, the dose of radiation will be 3750 cGy delivered in 15 daily fractions, 4-5 days a week. In locoregionally recurrent cases where the intent is to enhance locoregional control, the dose of radiation will be 5000 cGy delivered in 25 fractions, 4-5 days a week plus an optional 10-14 Gy boost to areas of gross tumor.
cisplatinDrug
Cisplatin treatment should be initiated following study registration. The dose of cisplatin is established as 25 mg/m^2 ivpb once a week (+ 3 days) for 1-2 weeks prior to radiation. The length of one cycle of Cisplatin is 21 days.
Biopsy of Target TumorProcedure or surgery
Biopsy of the tumor to be irradiated will be performed. Fresh tissue specimens will be sent to the laboratory for performance of the MSK-HRR Assay.
| Study group | Role | What they receive |
|---|---|---|
| Concurrent Cisplatin & Radiation Therapy | Experimental | Not described Receives: Radiation: external beam radiation therapy; Drug: cisplatin; Procedure: Biopsy of Target Tumor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response (RECIST 1.1 vs. PET Response Criteria (PRC) as Measurement Tools for Treatment Response)
RECIST 1.1 as measurement tools for treatment response.
Measured: 2 years from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study start14 Apr 2015
- Primary completion19 Dec 2022
- Study completion14 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Locally Recurrent/Metastatic Triple Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cedars-Sinai Medical Center
- Responsible party
- Sponsor
- Investigators
- Simon Powell, MD,PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02422498
- Sponsor's protocol ID
- 15-032
- Status last verified
- Mar 2026
- First submitted
- 14 Apr 2015
- Last updated
- 24 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Homologous Recombination Repair Status as a Biomarker of Response in Locally Recurrent/Metastatic Triple Negative Breast Cancer Patients Treated With Concurrent Cisplatin and Radiation Therapy
- ClinicalTrials.gov ID
- NCT02422498
- Acronym / sponsor ID
- 15-032
- Keywords
- Treated with Concurrent Cisplatin, Treated with Radiation Therapy, Homologous Recombination Repair Status, Biomarker of Response, 15-032, Patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Cedars-Sinai Medical Center
- Study start
- 14 Apr 2015 (actual)
- Primary completion
- 19 Dec 2022 (actual)
- Study completion
- 14 Apr 2028 (estimated)
- First posted
- 21 Apr 2015 (estimated)
- Results
- Posted 9 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is being done to find out if the results of a pre-treatment biopsy can predict response to cisplatin and radiation treatment for patients with metastatic or recurrent triple negative breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Concurrent Cisplatin & Radiation Therapy | Experimental | Radiation: external beam radiation therapy, Drug: cisplatin, Procedure: Biopsy of Target Tumor |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| external beam radiation therapyRadiation therapy to the target tumor will be delivered with external beam radiation therapy. In metastatic cases where the intent is palliative, the dose of radiation will be 3750 cGy delivered in 15 daily fractions, 4-5 days a week. In locoregionally recurrent cases where the intent is to enhance locoregional control, the dose of radiation will be 5000 cGy delivered in 25 fractions, 4-5 days a week plus an optional 10-14 Gy boost to areas of gross tumor. | Radiation | Concurrent Cisplatin & Radiation Therapy |
| cisplatinCisplatin treatment should be initiated following study registration. The dose of cisplatin is established as 25 mg/m^2 ivpb once a week (+ 3 days) for 1-2 weeks prior to radiation. The length of one cycle of Cisplatin is 21 days. | Drug | Concurrent Cisplatin & Radiation Therapy |
| Biopsy of Target TumorBiopsy of the tumor to be irradiated will be performed. Fresh tissue specimens will be sent to the laboratory for performance of the MSK-HRR Assay. | Procedure or surgery | Concurrent Cisplatin & Radiation Therapy |
Primary outcome
Response (RECIST 1.1 vs. PET Response Criteria (PRC) as Measurement Tools for Treatment Response)
Time frame: 2 years from baseline
RECIST 1.1 as measurement tools for treatment response.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Powell, MD,PhD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing external beam radiation therapy, cisplatin and Biopsy of Target Tumor in people with Locally Recurrent/Metastatic Triple Negative Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
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 18 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Response (RECIST 1.1 vs. PET Response Criteria (PRC) as Measurement Tools for Treatment Response) (time frame: 2 years from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2026.