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RecruitingPhase 1Phase 2NCT04215003

A Clinical Trial of Breast Cancer Neo-adjuvant Therapy Based on Molecular Pathway in FUSCC

This is a Phase Ib/II, Prospective , Open-label, Single Center, Bayesian Adaptive Design, Umbrella Study Evaluating the Efficacy and Safety of Neo-adjuvant Therapy in Patients With Breast Cancer.

Sponsor

Fudan University

Enrollment

20 participants

Start Date

Jan 20, 2020

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

Summary

This is a Phase Ib/II, prospective , open-label, single center, Bayesian adaptive design, umbrella study evaluating the efficacy and safety of neo-adjuvant therapy in patients with breast cancer.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a personalized pre-surgery (neoadjuvant) chemotherapy regimen for breast cancer patients, using tumor biology to select the most effective combination of drugs before surgical removal. **You may be eligible if...** - You are 18 to 70 years old - You have invasive ductal breast cancer confirmed by biopsy at stage IIB–IIIC - You have not received any chemotherapy or hormonal therapy before - Your cancer is measurable on scans - Your bone marrow, liver, and kidney function are adequate - Your life expectancy is more than 12 months **You may NOT be eligible if...** - Your cancer has spread to the brain or liver, or has distant metastases - You have another active cancer (except controlled cervical carcinoma in situ or basal cell skin cancer) - You are unable to consent or unwilling to undergo the planned treatment and biopsies Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGA

Paclitaxel: paclitaxel 80 mg/m2 ivgtt d1, d8, d15, 28 days per cycle. Carboplatin: carboplatin AUC=2 ivgtt d1, d8, d15, 28 days per cycle. Herceptin: 4 mg/kg (loading dose 8mg/kg) ivgtt d1,8,15, 22, 28 days per cycle,6 cycles. Pertuzumab: 420-mg ( loading dose 840mg) ivgtt d1, 21 days per cycle,6 cycles.

DRUGB

Paclitaxel: paclitaxel 80 mg/m2 ivgtt d1, d8, d15, 28 days per cycle. Carboplatin: carboplatin AUC=2 ivgtt d1, d8, d15, 28 days per cycle.

DRUGCL4

SHR6390（CDK4/6 inhibitor）125 mg qd(three week on one week off); oral letrozole 2.5 mg daily； Adebrelimab was given intravenously, 600mg each time, once every 2 weeks; Premenopause：Goserelin 3.6mg IM IM Q4W.

Locations(2)

Shao Zhimin

Shanghai, Please Select, China

Fudan University Shanghai Cancer Center

Shanghai, China

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NCT04215003

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