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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

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ClinicalTrials.gov Identifier: NCT02422498
Recruitment Status : Recruiting
First Posted : April 21, 2015
Last Update Posted : July 12, 2019
Sponsor:
Collaborator:
Cedars-Sinai Medical Center
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment Phase
Locally Recurrent/Metastatic Triple Negative Breast Cancer Radiation: external beam radiation therapy Drug: cisplatin Procedure: Biopsy of Target Tumor Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 2015
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Cisplatin

Arm Intervention/treatment
Experimental: Concurrent Cisplatin & Radiation Therapy Radiation: 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.

Drug: 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.

Procedure: 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.




Primary Outcome Measures :
  1. response (RECIST 1.1 vs. PET Response Criteria (PRC) as measurement tools for treatment response) [ Time Frame: 2 years ]
    Compare the efficacy of RECIST 1.1 vs. PET Response Criteria (PRC) as measurement tools for treatment response.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02422498


Contacts
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Contact: Simon Powell, MD, PhD 212 639-3639
Contact: George Plitas, M.D., Ph.D. 646-888-4587

Locations
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United States, New Jersey
Memorial Sloan Kettering at Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Simon Powell, MD, PhD    212-639-3639      
Memorial Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Simon Powell, MD, PhD    212-639-3639      
Memorial Sloan Kettering Bergen Recruiting
Montvale, New Jersey, United States, 07645
Contact: Simon Powell, MD, PhD    212-639-3639      
United States, New York
Memorial Sloan Kettering Cancer Center @ Suffolk Recruiting
Commack, New York, United States, 11725
Contact: Simon Powell, PhD    212-639-3639      
Memorial Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Simon Powell, MD, PhD    212-639-3639      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Simon Powell, MD, PhD    212-639-3639      
Contact: George Plitas, MD, PhD    646-888-4587      
Memorial Sloan Kettering at Mercy Medical Center Recruiting
Rockville Centre, New York, United States
Contact: Simon Powell, MD, PhD    212-639-3639      
Memorial Sloan Kettering Nassau Recruiting
Uniondale, New York, United States, 11553
Contact: Simon Powell, MD, PhD    212-639-3639      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Cedars-Sinai Medical Center
Investigators
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Principal Investigator: Simon Powell, MD,PhD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02422498     History of Changes
Other Study ID Numbers: 15-032
First Posted: April 21, 2015    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Keywords provided by Memorial Sloan Kettering Cancer Center:
Treated with Concurrent Cisplatin
Treated with Radiation Therapy
Homologous Recombination Repair Status
Biomarker of Response
15-032
Patients
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cisplatin
Antineoplastic Agents