Back to resultsNeoadjuvant Hormonal Therapy Combined With Chemoimmunotherapy (Neohttp)
Primary Purpose
HER2-positive Breast Cancer, ER-positive Breast Cancer
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
fulvestrant 500 mg
Docetaxel
Trastuzumab (H, 8mg/kg
Pertuzumab (P, 840 mg
Sponsored by
About this trial
This is an interventional treatment trial for HER2-positive Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status score < 1
- Absolute neutrophil count > 1500 mm3, platelet count ≥ 100×109 L, hemoglobin ≥ 8.5 g/dL
- 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)
- 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:
- Uncontrolled cardiac disease, such as angina, hypertension or significant arrhythmias
- 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
- Pregnant or lactating females
- Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements
- Concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements
Sites / Locations
- Western Regional Medical Center, Inc.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Protocol
Arm Description
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.
Outcomes
Primary Outcome Measures
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;
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT02345772
First Posted
January 19, 2015
Last Updated
January 22, 2018
Sponsor
Western Regional Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02345772
Brief Title
Neoadjuvant Hormonal Therapy Combined With Chemoimmunotherapy
Acronym
Neohttp
Official Title
Neoadjuvant Hormonal Therapy Combined With Chemoimmunotherapy (Taxotere, Trastuzumab and Pertuzumab) in Patients With HER2-positive and ER-Positive Breast Cancer (NeoHTTP Study)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Why Stopped
PI no longer at site. Data was not collected
Study Start Date
July 2014 (Actual)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Western Regional Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HER2-positive Breast Cancer, ER-positive Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Protocol
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
fulvestrant 500 mg
Other Intervention Name(s)
fulvestrant
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
Docetaxel (T) 75 mg/m2 every 3 weeks will be given for four cycles.
Intervention Type
Drug
Intervention Name(s)
Trastuzumab (H, 8mg/kg
Other Intervention Name(s)
Trastuzumab
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Pertuzumab (P, 840 mg
Other Intervention Name(s)
Pertuzumab
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pathological Complete Remission Rate
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;
Time Frame
one year
Secondary Outcome Measure Information:
Title
Partial Pathological Response Rate
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.
Time Frame
One Year
Title
QTA (Quantitative Texture Analysis)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Eastern Cooperative Oncology Group (ECOG) performance status score < 1
Absolute neutrophil count > 1500 mm3, platelet count ≥ 100×109 L, hemoglobin ≥ 8.5 g/dL
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)
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:
Uncontrolled cardiac disease, such as angina, hypertension or significant arrhythmias
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
Pregnant or lactating females
Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements
Concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jordan Waypa, FNP
Organizational Affiliation
Research Director
Official's Role
Study Director
Facility Information:
Facility Name
Western Regional Medical Center, Inc.
City
Goodyear
State/Province
Arizona
ZIP/Postal Code
85338
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Neoadjuvant Hormonal Therapy Combined With Chemoimmunotherapy
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