Locally Recurrent/Metastatic Triple Negative Breast Cancer Clinical Trial
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
| Verified date | December 2022 |
| Source | Memorial Sloan Kettering Cancer Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 49 |
| Est. completion date | December 19, 2022 |
| Est. primary completion date | December 19, 2022 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Memorial Sloan Kettering at Basking Ridge | Basking Ridge | New Jersey |
| United States | Memorial Sloan Kettering Cancer Center @ Suffolk | Commack | New York |
| United States | Memorial Sloan Kettering Westchester | Harrison | New York |
| United States | Memorial Sloan Kettering Monmouth | Middletown | New Jersey |
| United States | Memorial Sloan Kettering Bergen | Montvale | New Jersey |
| United States | Memorial Sloan Kettering Cancer Center | New York | New York |
| United States | Memorial Sloan Kettering Nassau | Uniondale | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Memorial Sloan Kettering Cancer Center | Cedars-Sinai Medical Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |