Anti-HER2 Therapy for Breast Cancer

Overseen By Olufunmilayo Olopade

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Chicago

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

Doctors leading this study would like to learn about providing cancer treatment/therapies to Nigerian women with breast cancer based on their human epidermal growth factor receptor 2 (HER2) status. This study will focus on the efficacy and safety of anti-HER2 cancer treatment before and after surgery.

Research Team

Olufunmilayo Olopade, MD

Principal Investigator

University of Chicago

Eligibility Criteria

This trial is for Nigerian women with a type of breast cancer that tests positive for HER2, which means the cancer grows in response to a certain protein. Participants should be preparing for or have completed surgery and are now considering further treatment.

Inclusion Criteria

I am a woman aged between 18 and 70.

Written informed consent must be obtained prior to any screening procedures

Required Initial Laboratory Data: Adequate hematologic, renal, and hepatic function as defined by specific criteria

Exclusion Criteria

I take medication for chest pain.

Participation in any investigational drug study within 4 weeks preceding the start of study treatment

My cancer has spread to distant parts of my body.

Treatment Details

Interventions

• Pertuzumab (Monoclonal Antibodies)
• Trastuzumab emtansine (Monoclonal Antibodies)

Trial Overview The study is testing how effective and safe anti-HER2 therapies like Tamoxifen, Docetaxel, Goserelin, Trastuzumab emtansine, Letrozole, and Pertuzumab Injection are when given before and after surgery to treat HER2+ breast cancer.

Participant Groups

Group I: Phase 2 - Operable (participants who are able to have surgery) Experimental Treatment 6 Interventions

Participants in this group will have breast cancer that shows a complete or incomplete response (as assessed by ultrasound) to the study drug combination given in phase 1 of study. Based on how their breast cancer responds to the phase 1 study drugs, participants in this group will: - undergo surgery and will continue to receive pertuzumab (600 mg) and trastuzumab (600 mg) for 36 weeks. Participants may also receive hormone therapy (as recommended by study doctor) based on status of breast cancer. This drug will be given as an injection under the skin. Some participants in this group may also receive tamoxifen (as an oral tablet; 20 mg daily for 10 years after surgery), letrozole (as an oral tablet 2.5 mg daily for 10 years after surgery) and/or goserelin (hormone injection 10.8 mg every 1-3 months) based on their human epidermal growth factor receptor 2 (HER2) status as assessed by the treating doctor.

Group II: Phase 2 - Inoperable (participants who are not able to have surgery) Experimental Treatment 1 Intervention

Participants in this group will have breast cancer that shows a partial response (as assessed by ultrasound) to the study drugs given in phase 1 or their breast cancer stayed the same or got worse after receiving study drugs during phase 1. Based on how their breast cancer responds to the phase 1 study drug regimen, participants in this group will receive trastuzumab emtansine (intravenously) plus standard chemotherapy as recommended by their doctor.

Group III: Phase 1: All Participants Experimental Treatment 3 Interventions

All participants will receive a combination of: * docetaxel (starting dose - 75 mg/m2), increasing to 100mg/m2 by cycle 2 (if tolerated) for 4-6 cycles (for a total of 18 weeks). Docetaxel will be give as an injection. * trastuzumab and pertuzumab (loading dose of 1200 mg of pertuzumab and 600 mg trastuzumab) for 52 weeks followed by 600 mg pertuzumab and 600 mg trastuzumab every 3 weeks for 15 cycles (for a total of 52 weeks). These two drugs will be given as subcutaneous injections under the skin.

Pertuzumab is already approved in Canada, Japan for the following indications:

Approved in Canada as Perjeta for:

• Early breast cancer
• Metastatic breast cancer

Approved in Japan as Perjeta for:

• Early breast cancer
• Metastatic breast cancer

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+