Trial Outcomes & Findings for 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 (NCT NCT02422498)
NCT ID: NCT02422498
Last Updated: 2024-02-09
Results Overview
RECIST 1.1 as measurement tools for treatment response.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
49 participants
Primary outcome timeframe
2 years
Results posted on
2024-02-09
Participant Flow
Participant milestones
| Measure |
Concurrent Cisplatin & Radiation Therapy
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.
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.
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.
|
|---|---|
|
Overall Study
STARTED
|
49
|
|
Overall Study
COMPLETED
|
45
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Concurrent Cisplatin & Radiation Therapy
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.
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.
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.
|
|---|---|
|
Overall Study
Inevaluable
|
4
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Concurrent Cisplatin & Radiation Therapy
n=49 Participants
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.
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.
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.
|
|---|---|
|
Age, Continuous
|
54 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
49 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsRECIST 1.1 as measurement tools for treatment response.
Outcome measures
| Measure |
Concurrent Cisplatin & Radiation Therapy
n=49 Participants
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.
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.
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.
|
|---|---|
|
Response (RECIST 1.1 vs. PET Response Criteria (PRC) as Measurement Tools for Treatment Response)
Partial Response
|
2 Participants
|
|
Response (RECIST 1.1 vs. PET Response Criteria (PRC) as Measurement Tools for Treatment Response)
Progression of Disease
|
25 Participants
|
|
Response (RECIST 1.1 vs. PET Response Criteria (PRC) as Measurement Tools for Treatment Response)
Not Entered
|
22 Participants
|
Adverse Events
Concurrent Cisplatin & Radiation Therapy
Serious events: 12 serious events
Other events: 45 other events
Deaths: 40 deaths
Serious adverse events
| Measure |
Concurrent Cisplatin & Radiation Therapy
n=49 participants at risk
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.
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.
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.
|
|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
4.1%
2/49 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
8.2%
4/49 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.0%
1/49 • 1 year
|
|
Infections and infestations
Breast infection
|
2.0%
1/49 • 1 year
|
|
Psychiatric disorders
Confusion
|
2.0%
1/49 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.0%
1/49 • 1 year
|
|
General disorders
Edema limbs
|
2.0%
1/49 • 1 year
|
|
General disorders
Fatigue
|
4.1%
2/49 • 1 year
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.0%
1/49 • 1 year
|
|
General disorders
Fever
|
2.0%
1/49 • 1 year
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.0%
1/49 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.0%
1/49 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.0%
1/49 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal & conn tissue disorder Other
|
2.0%
1/49 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/49 • 1 year
|
|
Investigations
Neutrophil count decreased
|
2.0%
1/49 • 1 year
|
|
Nervous system disorders
Paresthesia
|
2.0%
1/49 • 1 year
|
|
Investigations
Platelet count decreased
|
2.0%
1/49 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.0%
1/49 • 1 year
|
|
Infections and infestations
Skin infection
|
2.0%
1/49 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
1/49 • 1 year
|
|
Investigations
White blood cell decreased
|
2.0%
1/49 • 1 year
|
Other adverse events
| Measure |
Concurrent Cisplatin & Radiation Therapy
n=49 participants at risk
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.
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.
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.
|
|---|---|
|
General disorders
Fatigue
|
51.0%
25/49 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
36.7%
18/49 • 1 year
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
36.7%
18/49 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
36.7%
18/49 • 1 year
|
|
Investigations
White blood cell decreased
|
36.7%
18/49 • 1 year
|
|
Investigations
Neutrophil count decreased
|
32.7%
16/49 • 1 year
|
|
Investigations
Lymphocyte count decreased
|
26.5%
13/49 • 1 year
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
16.3%
8/49 • 1 year
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
16.3%
8/49 • 1 year
|
|
Metabolism and nutrition disorders
Anorexia
|
14.3%
7/49 • 1 year
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
14.3%
7/49 • 1 year
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
14.3%
7/49 • 1 year
|
|
Investigations
Platelet count decreased
|
14.3%
7/49 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
12.2%
6/49 • 1 year
|
|
Nervous system disorders
Dysgeusia
|
12.2%
6/49 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
12.2%
6/49 • 1 year
|
|
General disorders
Pain
|
12.2%
6/49 • 1 year
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.2%
6/49 • 1 year
|
|
Investigations
Alanine aminotransferase increased
|
10.2%
5/49 • 1 year
|
|
Gastrointestinal disorders
Dry mouth
|
10.2%
5/49 • 1 year
|
|
General disorders
Localized edema
|
10.2%
5/49 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
10.2%
5/49 • 1 year
|
|
Investigations
Weight Loss
|
10.2%
5/49 • 1 year
|
|
Nervous system disorders
Dizziness
|
8.2%
4/49 • 1 year
|
|
Ear and labyrinth disorders
Tinnitus
|
8.2%
4/49 • 1 year
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - other
|
6.1%
3/49 • 1 year
|
|
Reproductive system and breast disorders
Breast pain
|
6.1%
3/49 • 1 year
|
|
Investigations
Creatinine increased
|
6.1%
3/49 • 1 year
|
|
General disorders
Edema limbs
|
6.1%
3/49 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.1%
3/49 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.1%
3/49 • 1 year
|
Additional Information
Dr. Simon Powell, MD
Memorial Sloan Kettering Cancer Center
Phone: 212-639-3639
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place