Clinical trial NCT02345772: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: HER2-positive Breast Cancer
ER-positive Breast Cancer
Lead sponsor: Western Regional Medical Center
Sponsor class: OTHER
First posted: 2015-01-26
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pathological Complete Remission Rate
timeFrame: one year
Secondary outcomes:
measure: Partial Pathological Response Rate
timeFrame: One Year
measure: QTA (Quantitative Texture Analysis)
timeFrame: One year
Other outcomes:
Locations:
city: Goodyear
country: United States
facility: Western Regional Medical Center, Inc.
state: Arizona
Study officials:
affiliation: Research Director
name: Jordan Waypa, FNP
role: STUDY_DIRECTOR
References: