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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-14

Study Completion Date

2022-12-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Locally Recurrent/Metastatic Triple Negative Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Concurrent Cisplatin & Radiation Therapy

Group Type EXPERIMENTAL

external beam radiation therapy

Intervention Type 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.

cisplatin

Intervention Type 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.

Biopsy of Target Tumor

Intervention Type 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.

Interventions

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external beam radiation therapy

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.

Intervention Type RADIATION

cisplatin

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.

Intervention Type DRUG

Biopsy of Target Tumor

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No