Clinical trial NCT02422498: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Cedars-Sinai Medical Center
First posted: 2015-04-21
Enrollment: 49
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Response (RECIST 1.1 vs. PET Response Criteria (PRC) as Measurement Tools for Treatment Response)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering at Basking Ridge
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Suffolk
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Simon Powell, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: