HER2-positive Breast Cancer, ER-positive Breast Cancer
Conditions
Brief summary
Hormonal therapy administered before surgery in ER-positive and HER2-positive patients with breast cancer.
Detailed description
Hormonal therapy with fulvestrant 500 mg to be administered before surgery With docetaxel, Trastuzumab, and pertuzumab to determine pathological complete remission rate at the time of surgery in ER-positive and HER2-positive patients with breast cancer.
Interventions
Hormonal therapy with fulvestrant 500 mg will be administered intramuscularly on days 1, 15 of the first cycle, and thereafter on day 1 of every 28-day cycle for up to 5 cycles before surgery.
DRUGDocetaxel
Docetaxel (T) 75 mg/m2 every 3 weeks will be given for four cycles.
DRUGTrastuzumab (H, 8mg/kg
Trastuzumab (H, 8mg/kg for 1st cycle, then 6 mg/kg in subsequent cycles before and after surgery), pertuzumab (P, 840 mg for 1st cycle, then 420 mg in subsequent 3 cycles) will be given concurrently with docetaxel for a total of 4 cycles before surgery.
DRUGPertuzumab (P, 840 mg
Trastuzumab (H, 8mg/kg for 1st cycle, then 6 mg/kg in subsequent cycles before and after surgery), pertuzumab (P, 840 mg for 1st cycle, then 420 mg in subsequent 3 cycles) will be given concurrently with docetaxel for a total of 4 cycles before surgery.
Sponsors
Western Regional Medical Center
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
1. Patients ≥ 18 years of age with histologically, and radiographically confirmed non-metastatic ER-positive (defined as ≥30% of positive cells) and HER2-positive (defined as overexpression by immunohistochemistry (3+) or 2+ and positive by defined by fluorescence or dual in situ hybridization.) breast cancer with minimal tumor size over 2 cm (≥T2 lesion) to receive neoadjuvant chemotherapy recommended by the treating physician 2. Eastern Cooperative Oncology Group (ECOG) performance status score \< 1 3. Absolute neutrophil count \> 1500 mm3, platelet count ≥ 100×109 L, hemoglobin ≥ 8.5 g/dL 4. Serum creatinine ≤1.5 times the upper limit of the normal range, total bilirubin ≤ 1.5 X ULN (≤ 3 mg/dL if clinically diagnosed with Gilbert syndrome) AST/ALT ≤ 2.5 X ULN (AST/ALT ≤ 5X ULN if clinically diagnosed with Gilbert syndrome) 5. Women of child-bearing potential (i.e., women who are pre-menoposaul or not surgically sterile) must have a negative serum pregnancy test within 2 weeks prior to beginning treatment
Exclusion criteria
1. Uncontrolled cardiac disease, such as angina, hypertension or significant arrhythmias 2. LVEF (left ventricular ejection fraction) \< 50% on any prior assessment. Note: Assessment of LVEF is done before and after trastuzumab-based chemotherapy as standard of care 3. Pregnant or lactating females 4. Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements 5. Concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological Complete Remission Rate | one year | To determine pathological complete remission rate at the time of surgery in ER-positive and HER2-positive breast cancer patients undergoing neoadjuvant chemoimmunotherapy (docetaxel, trastuzumab, pertuzumab) concurrently with neoadjuvant hormonal therapy with fulvestrant. Note: pCR, defined as the absence of invasive neoplastic cells of the primary tumor in the breast, remaining in-situ lesions are allowed, ypT0-is; |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Partial Pathological Response Rate | One Year | Partial pathological response rate at the time of surgery and biomarker changes in breast cancer (biopsy vs residual tumor) before and after neoadjuvant chemotherapy Note: pPR, defined as residual invasive disease of 1cm, ypT1a-b. |
| QTA (Quantitative Texture Analysis) | One year | QTA (Quantitative Texture Analysis): will be obtained from baseline mammogram and the correlation with clinical outcome after neoadjuvant therapy will be performed. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Protocol Hormonal therapy with fulvestrant 500 mg will be administered intramuscularly on days 1, 15 of the first cycle, and thereafter on day 1 of every 28-day cycle for up to 5 cycles before surgery. Docetaxel (T) 75 mg/m2 every 3 weeks will be given for four cycles. Trastuzumab (H, 8mg/kg for 1st cycle, then 6 mg/kg in subsequent cycles before and after surgery), pertuzumab (P, 840 mg for 1st cycle, then 420 mg in subsequent 3 cycles) will be given concurrently with docetaxel for a total of 4 cycles before surgery. | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Pathological Complete Remission Rate
To determine pathological complete remission rate at the time of surgery in ER-positive and HER2-positive breast cancer patients undergoing neoadjuvant chemoimmunotherapy (docetaxel, trastuzumab, pertuzumab) concurrently with neoadjuvant hormonal therapy with fulvestrant. Note: pCR, defined as the absence of invasive neoplastic cells of the primary tumor in the breast, remaining in-situ lesions are allowed, ypT0-is;
Time frame: one year
Population: Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information.After much effort, results were not able to be retained.
Secondary
Partial Pathological Response Rate
Partial pathological response rate at the time of surgery and biomarker changes in breast cancer (biopsy vs residual tumor) before and after neoadjuvant chemotherapy Note: pPR, defined as residual invasive disease of 1cm, ypT1a-b.
Time frame: One Year
Population: Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information.After much effort, results were not able to be retained.
Secondary
QTA (Quantitative Texture Analysis)
QTA (Quantitative Texture Analysis): will be obtained from baseline mammogram and the correlation with clinical outcome after neoadjuvant therapy will be performed.
Time frame: One year
Population: Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information.After much effort, results were not able to be retained.