Neoadjuvant Hormonal Therapy Combined With Chemoimmunotherapy (Neohttp)

Western Regional Medical Center

Status and phase: Terminated; Phase 2; Phase 1

Conditions: ER-positive Breast Cancer; HER2-positive Breast Cancer

Treatments: Drug: Trastuzumab (H, 8mg/kg; Drug: Docetaxel; Drug: Pertuzumab (P, 840 mg; Drug: fulvestrant 500 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT02345772

WIRB 20140462

Details and patient eligibility

About

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

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Treatment Protocol

Experimental group

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.

Treatment:

Drug: fulvestrant 500 mg

Drug: Pertuzumab (P, 840 mg

Drug: Docetaxel

Drug: Trastuzumab (H, 8mg/kg