Neoadjuvant Hormonal Therapy Combined With Chemoimmunotherapy
(Neohttp Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Western Regional Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

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

Research Team

Jordan Waypa, FNP

Principal Investigator

Research Director

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

See 2 more

Treatment Details

Interventions

Docetaxel (Chemotherapy)
Fulvestrant (Hormone Therapy)
Pertuzumab (Monoclonal Antibodies)
Trastuzumab (Monoclonal Antibodies)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment ProtocolExperimental Treatment4 Interventions

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.