Trial Outcomes & Findings for Effect of Chemotherapy and Radiation Prior to Surgery for Triple Negative Breast Cancer (NCT NCT00603408)
NCT ID: NCT00603408
Last Updated: 2016-08-19
Results Overview
* Complete response: disappearance of all target lesions, non-target lesions, and normalization of tumor marker level * Partial response: at least a 30% decrease in the sum of the longest diameter (LD) of the target lesions taking as reference the baseline sum LD * Stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since the treatment started, * Progressive disease: at least a 20% increase in the sum of the LD of the target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, appearance of one more new lesions, or unequivocal progression of existing non-target lesions.
TERMINATED
PHASE2
5 participants
At the time of surgery (week 13)
2016-08-19
Participant Flow
Participant milestones
| Measure |
Cisplatin + Radiation + Recommended Surgery
Cisplatin 75 mg/m\^2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10
Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.
Surgery (recommended) mastectomy with/without axillary lymph node dissection
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Chemotherapy and Radiation Prior to Surgery for Triple Negative Breast Cancer
Baseline characteristics by cohort
| Measure |
Cisplatin + Radiation + Recommended Surgery
n=5 Participants
Cisplatin 75 mg/m2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10
Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.
Surgery (recommended) mastectomy with/without axillary lymph node dissection
|
|---|---|
|
Age, Continuous
|
52 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: At the time of surgery (week 13)* Complete response: disappearance of all target lesions, non-target lesions, and normalization of tumor marker level * Partial response: at least a 30% decrease in the sum of the longest diameter (LD) of the target lesions taking as reference the baseline sum LD * Stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since the treatment started, * Progressive disease: at least a 20% increase in the sum of the LD of the target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, appearance of one more new lesions, or unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
Cisplatin + Radiation + Recommended Surgery
n=5 Participants
Cisplatin 75 mg/m\^2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10
Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.
Surgery (recommended) mastectomy with/without axillary lymph node dissection
|
|---|---|
|
Overall Response
Partial response
|
3 participants
|
|
Overall Response
Stable disease
|
0 participants
|
|
Overall Response
Complete response
|
2 participants
|
|
Overall Response
Progressive disease
|
0 participants
|
SECONDARY outcome
Timeframe: Until study was terminated (23.5 months)Population: At the time of study termination, no participants had experienced disease progression.
Time to disease progression: time from registration until objective tumor progression; does not include deaths
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Until study was terminated (23.5 months)OS = Time from registration until death from any cause
Outcome measures
| Measure |
Cisplatin + Radiation + Recommended Surgery
n=5 Participants
Cisplatin 75 mg/m\^2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10
Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.
Surgery (recommended) mastectomy with/without axillary lymph node dissection
|
|---|---|
|
Overall Survival Rate (OS)
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: 30 days post surgery (week 17-18)Outcome measures
| Measure |
Cisplatin + Radiation + Recommended Surgery
n=5 Participants
Cisplatin 75 mg/m\^2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10
Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.
Surgery (recommended) mastectomy with/without axillary lymph node dissection
|
|---|---|
|
Number of Participants With Surgical Complications
|
0 participants
|
SECONDARY outcome
Timeframe: 30 days post surgery (week 17-18)The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for all toxicity reporting. All detailed information regarding serious and other adverse events are listed in the Adverse Event module of these results.
Outcome measures
| Measure |
Cisplatin + Radiation + Recommended Surgery
n=5 Participants
Cisplatin 75 mg/m\^2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10
Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.
Surgery (recommended) mastectomy with/without axillary lymph node dissection
|
|---|---|
|
Number of Participants With Medical Toxicities
|
5 participants
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: Collecting bone marrow samples were optional and at the time of surgery only 2 patients participated and at the time of port removal submission none of the patients participated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsPopulation: Collecting tissue from the optional mastectomy was optional and was not collected on any of the patients.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At time of IVAD placement and at time of surgeryPopulation: Collecting tissue from the optional mastectomy was optional and was not collected on any of the patients.
Outcome measures
Outcome data not reported
Adverse Events
Cisplatin + Radiation + Recommended Surgery
Serious adverse events
| Measure |
Cisplatin + Radiation + Recommended Surgery
n=5 participants at risk
Cisplatin 75 mg/m\^2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10
Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.
Surgery (recommended) mastectomy with/without axillary lymph node dissection
|
|---|---|
|
Metabolism and nutrition disorders
Hyperglycemia
|
20.0%
1/5
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
20.0%
1/5
|
|
Infections and infestations
Viral hepatitis
|
20.0%
1/5
|
|
Infections and infestations
Infection unknown ANC - general wound
|
20.0%
1/5
|
|
Skin and subcutaneous tissue disorders
Burn due to radiation therapy
|
20.0%
1/5
|
Other adverse events
| Measure |
Cisplatin + Radiation + Recommended Surgery
n=5 participants at risk
Cisplatin 75 mg/m\^2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10
Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.
Surgery (recommended) mastectomy with/without axillary lymph node dissection
|
|---|---|
|
Immune system disorders
Allergic reaction
|
20.0%
1/5
|
|
Ear and labyrinth disorders
Tinnitus
|
20.0%
1/5
|
|
Blood and lymphatic system disorders
Hemoglobin
|
80.0%
4/5
|
|
Investigations
Leukocytes
|
40.0%
2/5
|
|
Investigations
Lymphopenia
|
80.0%
4/5
|
|
Investigations
Neutrophils
|
20.0%
1/5
|
|
Investigations
Platelets
|
40.0%
2/5
|
|
Cardiac disorders
Cardiac General - Other
|
20.0%
1/5
|
|
Vascular disorders
Hypertension
|
60.0%
3/5
|
|
Vascular disorders
Hypotension
|
20.0%
1/5
|
|
Investigations
INR
|
20.0%
1/5
|
|
Investigations
PTT
|
40.0%
2/5
|
|
General disorders
Constitutional symptoms - other
|
20.0%
1/5
|
|
General disorders
Fatigue
|
100.0%
5/5
|
|
Psychiatric disorders
Insomnia
|
20.0%
1/5
|
|
General disorders
Rigors/chills
|
20.0%
1/5
|
|
Social circumstances
Alopecia
|
20.0%
1/5
|
|
Injury, poisoning and procedural complications
Bruising
|
20.0%
1/5
|
|
Skin and subcutaneous tissue disorders
Dermatology - other
|
60.0%
3/5
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
20.0%
1/5
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
1/5
|
|
Skin and subcutaneous tissue disorders
Rash: dermatitis associated with radiation therapy
|
100.0%
5/5
|
|
Vascular disorders
Hot flashes
|
20.0%
1/5
|
|
Metabolism and nutrition disorders
Anorexia
|
40.0%
2/5
|
|
Gastrointestinal disorders
Constipation
|
40.0%
2/5
|
|
Gastrointestinal disorders
Dehydration
|
20.0%
1/5
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
1/5
|
|
Gastrointestinal disorders
Esophagitis
|
20.0%
1/5
|
|
Gastrointestinal disorders
Gastritis
|
20.0%
1/5
|
|
Gastrointestinal disorders
Heartburn
|
20.0%
1/5
|
|
Gastrointestinal disorders
Hemmorrhoids
|
20.0%
1/5
|
|
Gastrointestinal disorders
Nausea
|
60.0%
3/5
|
|
Gastrointestinal disorders
Taste alteration
|
20.0%
1/5
|
|
Gastrointestinal disorders
Vomiting
|
40.0%
2/5
|
|
Vascular disorders
Hematoma
|
20.0%
1/5
|
|
General disorders
Edema: head and neck
|
20.0%
1/5
|
|
General disorders
Edema: limb
|
60.0%
3/5
|
|
Blood and lymphatic system disorders
Lymphatics - other (specify)
|
20.0%
1/5
|
|
Metabolism and nutrition disorders
Albumin, serum-low
|
40.0%
2/5
|
|
Investigations
Alkaline phosphatase
|
60.0%
3/5
|
|
Investigations
ALT
|
60.0%
3/5
|
|
Investigations
AST
|
20.0%
1/5
|
|
Investigations
Bilirubin
|
20.0%
1/5
|
|
Investigations
Creatinine
|
20.0%
1/5
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
60.0%
3/5
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
40.0%
2/5
|
|
Metabolism and nutrition disorders
Hypokalemia
|
20.0%
1/5
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
40.0%
2/5
|
|
Investigations
Hyponatremia
|
60.0%
3/5
|
|
Musculoskeletal and connective tissue disorders
Extremity - upper (function)
|
20.0%
1/5
|
|
Injury, poisoning and procedural complications
Seroma
|
20.0%
1/5
|
|
Nervous system disorders
Dizziness
|
20.0%
1/5
|
|
Nervous system disorders
Memory impairment
|
20.0%
1/5
|
|
Psychiatric disorders
Mood alteration - anxiety
|
40.0%
2/5
|
|
Psychiatric disorders
Mood alteration - depression
|
20.0%
1/5
|
|
Nervous system disorders
Neuropathy - sensory
|
20.0%
1/5
|
|
Eye disorders
Ocular - other (specify)
|
20.0%
1/5
|
|
General disorders
Pain - general (Pain NOS)
|
20.0%
1/5
|
|
General disorders
Pain - General (tumor pain)
|
20.0%
1/5
|
|
Musculoskeletal and connective tissue disorders
Pain - musculoskeletal (joint)
|
40.0%
2/5
|
|
Musculoskeletal and connective tissue disorders
Pain - musculoskeletal (neck)
|
20.0%
1/5
|
|
Nervous system disorders
Pain - Neurology (head/headache)
|
20.0%
1/5
|
|
General disorders
Pain - Other (specify)
|
40.0%
2/5
|
|
Respiratory, thoracic and mediastinal disorders
Pain - Pulmonary (chest wall)
|
20.0%
1/5
|
|
Respiratory, thoracic and mediastinal disorders
Pain - Pulmonary (Chest/thorax NOS)
|
40.0%
2/5
|
|
Reproductive system and breast disorders
Pain - Sexual (breast)
|
20.0%
1/5
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
1/5
|
|
Reproductive system and breast disorders
Sexual - Other (specify)
|
20.0%
1/5
|
|
Reproductive system and breast disorders
Vaginitis
|
20.0%
1/5
|
|
Injury, poisoning and procedural complications
Surgery Injury - skin (breast)
|
20.0%
1/5
|
|
Vascular disorders
Phlebitis
|
20.0%
1/5
|
|
Vascular disorders
Thrombosis/embolism (vascular access-related)
|
20.0%
1/5
|
Additional Information
Rebecca Aft, M.D., Ph.D.
Washington University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place