Neoadjuvant Hormonal Therapy Combined With Chemoimmunotherapy

HER2-positive Breast Cancer Clinical Trial

— 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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02345772
• Other study ID #: WIRB 20140462
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: January 19, 2015
• Last updated: January 22, 2018
• Start date: July 2014
• Est. completion date: November 2015

Study information

• Verified date: January 2018
• Source: Western Regional Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hormonal therapy administered before surgery in ER-positive and HER2-positive patients with breast cancer.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• ER-positive Breast Cancer
• HER2-positive Breast Cancer

Intervention

Drug:
• fulvestrant 500 mg
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
Docetaxel (T) 75 mg/m2 every 3 weeks will be given for four cycles.
• Trastuzumab (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.
• Pertuzumab (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.

Locations

Country	Name	City	State
United States	Western Regional Medical Center, Inc.	Goodyear	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Western Regional Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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;	one year
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.	One Year
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.	One year