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

NCT02422498 | Active Not Recruiting Phase 2 Results

• 1 other identifier: 15-032
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Locally Recurrent/Metastatic Triple Negative Breast Cancer

Keywords

Treated with Concurrent Cisplatin; Treated with Radiation Therapy; Homologous Recombination Repair Status; Biomarker of Response; 15-032; Patients

Outcome Measures

Primary Outcomes (1)

• Response (RECIST 1.1 vs. PET Response Criteria (PRC) as Measurement Tools for Treatment Response)

  RECIST 1.1 as measurement tools for treatment response.

  2 years from baseline

Study Arms (1)

Concurrent Cisplatin & Radiation Therapy

EXPERIMENTAL

Radiation: external beam radiation therapy; Drug: cisplatin; Procedure: Biopsy of Target Tumor

Interventions

external beam radiation therapy RADIATION

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.

Concurrent Cisplatin & Radiation Therapy

cisplatin DRUG

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.

Concurrent Cisplatin & Radiation Therapy

Biopsy of Target Tumor PROCEDURE

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.

Concurrent Cisplatin & Radiation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Cedars-Sinai Medical Center: collaborator

Study Sites (7)

Memorial Sloan Kettering at Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Cancer Center @ Suffolk

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Cisplatin

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Results Point of Contact

• Title: Dr. Simon Powell, MD
• Organization: Memorial Sloan Kettering Cancer Center

powells@mskcc.org

212-639-3639

Study Officials

• Simon Powell, MD,PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2015
• First Posted: April 21, 2015
• Study Start: April 14, 2015
• Primary Completion: December 19, 2022
• Study Completion (Estimated): April 14, 2028
• Last Updated: March 24, 2026
• Results First Posted: February 9, 2024

Record last verified: 2026-03

Locations

US (7)