Study on Anti-HER2 Therapy for Nigerian Women with HER2+ Breast Cancer Before and After Surgery

Sponsor: University of Chicago

Sponsor score: 0
Inactive

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.

Patient Parameters

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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