Breast Cancer
Conditions
Keywords
breast cancer, triple negative, TNBC, triple negative breast cancer
Brief summary
The purpose of this study is to determine whether the combination of docetaxel and carboplatin is an effective treatment for patients with triple negative breast cancer.
Detailed description
PRIMARY OBJECTIVE: To determine whether neoadjuvant docetaxel and carboplatin will increase the pCR rate in TNBC compared to historical controls. Pathologic complete response (pCR) will be defined as no residual invasive breast cancer in the breast and ipsilateral axillary lymph node (ypT0-is ypN0).
Interventions
DRUGDocetaxel
Docetaxel 75 mg/m2 intravenously on day 1 of each 21-day cycle. Number of Cycles: 6
DRUGCarboplatin
Carboplatin AUC 6 intravenously on day 1 of each 21-day cycle. Number of Cycles: 6
Sponsors
Mothaffar Rimawi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients must be 18 years of age or older. * All patients must be diagnosed with invasive breast cancer. * Breast cancer must be ER-negative, and HER-2 negative according to CAP/ASCO biomarkers testing guidelines. Tumors may be PgR positive with an Allred score of less than 5. * Primary breast tumor size at least 2 cm in one dimension by clinical or radiographic exam. Patients who have multicentric breast cancer are eligible if each lesion is estrogen receptor negative and HER2-negative. In that case, one lesion needs to be identified as the index lesion to be followed for clinical response. The index lesion must also be the lesion from which core biopsies are obtained. * Patients with inflammatory breast cancer are eligible if they meet both of the following criteria: 1. Patient has an underlying, clinically palpable breast mass of at least 2cm, AND 2. a corresponding lesion is visualized on mammogram or ultrasound * Normal bone marrow and organ function as defined below: * Leukocytes \> 3,000/mcL * Absolute neutrophil count \> 1,200/mcl * Platelets \> 100,000/mcl * Serum bilirubin ≤ institutional 1.5 times upper limit of normal (ULN) * Aspartate aminotransferase/alanine aminotransferase ≤ 2.5 times ULN * Creatinine ≤ 1.5 ULN * Women of childbearing potential (defined as women under the age of 55 with intact ovaries and uterus) must agree to use adequate contraception prior to study entry and for the duration of study participation. They must also have a negative urine pregnancy test within 7 days of starting treatment. * Ability to understand and willingness to sign an IRB approved written informed consent document and follow study procedures including willingness to undergo study biopsies.
Exclusion criteria
* Any prior systemic therapy for breast cancer within 5 years. * A history of other malignancy ≤ 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix. * Patients with known bilateral invasive breast cancer. Patients with contralateral in situ breast carcinoma are eligible. * Inflammatory breast cancer. * Patients with confirmed stage IV disease. * Currently receiving any other investigational agents. * A history of allergic reactions attributed to compounds of similar chemical or biologic composition to docetaxel or carboplatin. * Known to be seropositive for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV). * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * If the patient is otherwise not deemed a good study candidate by sole discretion of the principal investigator. * Patient is pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathologic Complete Response | At the time of definitive surgery (approximately 4-5 months after beginning chemotherapy) | This is the complete disappearance of invasive cancer in the breast at the time of surgery |
Countries
United States
Participant flow
Pre-assignment details
Patient eligibility is confirmed by both the study coordinator and a Lester & Sue Smith Breast Center physician. If a patient does not meet an inclusion criterion, or meets an exclusion criterion, as listed in the protocol section, the patient is excluded.
Participants by arm
| Arm | Count |
|---|---|
| Docetaxel/Carboplatin Docetaxel 75 mg/m2 plus Carboplatin AUC 6 IV on Day 1 of each 21 day cycle for 6 cycles
Docetaxel/Carboplatin: Docetaxel 75 mg/m2 plus Carboplatin AUC 6 IV (in the vein) on day 1 of each 21-day cycle. Number of Cycles: 6 | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Docetaxel/Carboplatin |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 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 | 0 Participants |
| Race (NIH/OMB) White | 22 Participants |
| Region of Enrollment United States | 25 Participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 25 |
| other Total, other adverse events | 16 / 25 |
| serious Total, serious adverse events | 3 / 25 |
Outcome results
Primary
Pathologic Complete Response
This is the complete disappearance of invasive cancer in the breast at the time of surgery
Time frame: At the time of definitive surgery (approximately 4-5 months after beginning chemotherapy)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Docetaxel/Carboplatin | Pathologic Complete Response | 10 Participants |