Description:
Hormonal therapy administered before surgery in ER-positive and HER2-positive patients with
breast cancer.
Title
- Brief Title: Neoadjuvant Hormonal Therapy Combined With Chemoimmunotherapy
- Official Title: Neoadjuvant Hormonal Therapy Combined With Chemoimmunotherapy (Taxotere, Trastuzumab and Pertuzumab) in Patients With HER2-positive and ER-Positive Breast Cancer (NeoHTTP Study)
Clinical Trial IDs
- ORG STUDY ID:
WIRB 20140462
- NCT ID:
NCT02345772
Conditions
- HER2-positive Breast Cancer
- ER-positive Breast Cancer
Interventions
Drug | Synonyms | Arms |
---|
fulvestrant 500 mg | fulvestrant | Treatment Protocol |
Docetaxel | Taxotere | Treatment Protocol |
Trastuzumab (H, 8mg/kg | Trastuzumab | Treatment Protocol |
Pertuzumab (P, 840 mg | Pertuzumab | Treatment Protocol |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Treatment Protocol | Experimental | 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. | - fulvestrant 500 mg
- Docetaxel
- Trastuzumab (H, 8mg/kg
- Pertuzumab (P, 840 mg
|
Eligibility Criteria
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Pathological Complete Remission Rate |
Time Frame: | one year |
Safety Issue: | |
Description: | 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 Outcome Measures
Measure: | Partial Pathological Response Rate |
Time Frame: | One Year |
Safety Issue: | |
Description: | 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. |
Measure: | QTA (Quantitative Texture Analysis) |
Time Frame: | One year |
Safety Issue: | |
Description: | QTA (Quantitative Texture Analysis): will be obtained from baseline mammogram and the correlation with clinical outcome after neoadjuvant therapy will be performed. |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Terminated |
Lead Sponsor: | Western Regional Medical Center |
Last Updated
February 20, 2018