Breast Cancer
Conditions
Keywords
triple negative, breast cancer, adjuvant therapy, Carboplatin, chemotherapy, radiation therapy, chemo-radiotherapy, accelerated radiotherapy
Brief summary
The purpose of this study is to determine the safety and effectiveness of a combination of chemotherapy and radiotherapy in breast cancer patients after breast surgery.
Detailed description
Preliminary experience in the neo-adjuvant setting of Locally Advanced Breast Cancer (LABC) has recently demonstrated that hormone receptors negative patients have approximately 50% chance to achieve a pathological response after concurrent chemo-radiation. In a multi-institutional collaboration of 105 patients it was found that triple negative (TN) tumor carriers achieved pathological response in 54% of the cases and that the response reflected on 5-year disease free survival and overall survival. Our group has speculated that these effects on the risk of distant recurrence could depend on the recovery of antitumor immunity among the patients achieving pathological response, after tumor cell death induced by concurrent chemo-radiation. The investigators are proposing a novel study that translates these findings to the adjuvant setting of TN tumors. TN breast cancer is a more aggressive form of the disease often coinciding with basal-like tumors. BRCA mutated-cancer is more frequently TN. The current protocol converges the experience NYU has developed in accelerated prone breast radiotherapy with encouraging finding from the use of concurrent chemoradiation in LABC. The investigators will study the feasibility of combining weekly carboplatin with concurrent 3-weeks prone breast radiotherapy in the adjuvant setting of 35 women with TN tumors, after segmental mastectomy and nodal assessment. Primary endpoint of the study is acute toxicity of the combined regimen, with a target of \< 25% of grade II-III dermatitis.
Interventions
DRUGCarboplatin
IV, weekly for 6 weeks, AUC of 2.0
RADIATION3D-RT or IMRT
From week 2 to week 4 in the 6-week Carboplatin treatment: Whole Breast 3D-RT or IMRT at 2.7 Gy X 15 fractions (5 times/wk x 3 wks=40.50 Gy), then the second and third Friday, 3 Gy to the tumor bed only X 2 fractions, Total dose to tumor bed = 46.5 Gy
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age older than 18 * Pre- or post-menopausal women with Stage I and II breast cancer, triple negative tumors * Biopsy-proven invasive breast cancer, excised with negative margins of at least 1 mm * Status post segmental mastectomy, after sentinel node biopsy and/or axillary node dissection (Tumors \< 5 mm in size do not require nodal assessment) or after mastectomy * No previous chemotherapy * Patient needs to be able to understand and demonstrate willingness to sign a written informed consent document
Exclusion criteria
* Previous radiation therapy to the ipsilateral breast * Active connective tissue disorders, such as lupus or scleroderma * Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Patients Who Developed Grade 2-3 Acute Radiation Dermatitis Within 60 Days Post-RT | 60 days post-RT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Experience Acute Toxicities at or More Than 6 Months After Completion of Radiation Treatment (RT) | 6 months to 5 year post-RT | Acute Toxicities include all Grade 1 toxicities |
| Number of Patients Who Experience Grade 2 or Higher Late Toxicities at or More Than 6 Months After Completion of Radiation Treatment (RT) | 6 months to 5 years post-RT | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ChemoRT Concurrent Carboplatin and Radiotherapy
Carboplatin: IV, weekly for 6 weeks, AUC of 2.0
3D-RT or IMRT: From week 2 to week 4 in the 6-week Carboplatin treatment: Whole Breast 3D-RT or IMRT at 2.7 Gy X 15 fractions (5 times/wk x 3 wks=40.50 Gy), then the second and third Friday, 3 Gy to the tumor bed only X 2 fractions, Total dose to tumor bed = 46.5 Gy | 90 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | ChemoRT |
|---|---|
| Age, Continuous | 56.83 years STANDARD_DEVIATION 12.33 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 57 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Region of Enrollment United States | 90 participants |
| Sex: Female, Male Female | 90 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 6 / 90 |
| other Total, other adverse events | 0 / 90 |
| serious Total, serious adverse events | 0 / 90 |
Outcome results
Primary
Number of Patients Who Developed Grade 2-3 Acute Radiation Dermatitis Within 60 Days Post-RT
Time frame: 60 days post-RT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ChemoRT | Number of Patients Who Developed Grade 2-3 Acute Radiation Dermatitis Within 60 Days Post-RT | 8 Participants |
Secondary
Number of Patients Who Experience Acute Toxicities at or More Than 6 Months After Completion of Radiation Treatment (RT)
Acute Toxicities include all Grade 1 toxicities
Time frame: 6 months to 5 year post-RT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ChemoRT | Number of Patients Who Experience Acute Toxicities at or More Than 6 Months After Completion of Radiation Treatment (RT) | 67 Participants |
Secondary
Number of Patients Who Experience Grade 2 or Higher Late Toxicities at or More Than 6 Months After Completion of Radiation Treatment (RT)
Time frame: 6 months to 5 years post-RT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ChemoRT | Number of Patients Who Experience Grade 2 or Higher Late Toxicities at or More Than 6 Months After Completion of Radiation Treatment (RT) | 18 Participants |