Study on Anti-HER2 Therapy for Nigerian Women with HER2+ Breast Cancer Before and After Surgery
Sponsor: University of Chicago
ClinicalTrials ID:NCT06348134
This clinical trial is exploring the effectiveness and safety of anti-HER2 therapy in Nigerian women with HER2-positive breast cancer, both before and after surgery. Participants will receive a combination of trastuzumab, pertuzumab, and chemotherapy.
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Program Overview
The study aims to evaluate how well anti-HER2 therapy works and how safe it is for Nigerian women with HER2-positive breast cancer. The treatment involves using a combination of drugs, including trastuzumab and pertuzumab (known as PHESGO), along with chemotherapy, given before and after surgery.
Description
This study focuses on Nigerian women with HER2-positive breast cancer to see if anti-HER2 therapy is effective and safe when given before and after surgery. Participants will receive a combination of trastuzumab and pertuzumab (PHESGO) plus chemotherapy. The goal is to understand how well this treatment works in shrinking tumors and preventing cancer from returning.
Eligibility Criteria
Inclusion Criteria
- Women aged 18 to 70 years old.
- Have a breast tumor that is at least 2 cm in size and can be measured by ultrasound.
- Diagnosed with HER2-positive breast cancer.
- Cancer is in stages 2A to 3C.
- Have not received chemotherapy for this cancer before.
- In good general health with a performance status score of 0 to 3.
- Not pregnant or nursing, and willing to use hormone therapy and contraception.
- Have adequate blood, kidney, and liver function based on specific lab tests.
- Heart function must be normal with an ejection fraction of 55% or higher.
Exclusion Criteria
- Pregnant or breastfeeding women, or those not using effective contraception.
- Cancer has spread to distant parts of the body.
- Have serious, uncontrolled infections.
- Have received more than 4 weeks of tamoxifen therapy for this cancer.
- Have had other cancers in the last 5 years, except for certain skin or cervical cancers.
- Participated in another drug study within the last 4 weeks.
- Have serious medical conditions that could affect participation, such as uncontrolled infections, HIV, heart problems, or uncontrolled diabetes.
- Not willing or able to follow the study protocol.
- Have HER2-negative breast cancer.
- Have a history of heart failure or certain heart conditions.
- Have poorly controlled high blood pressure.
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