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Assessing the Efficacy and Safety of Anti-HER2 Therapy in Nigerian Women With HER2+ Breast Cancer Before and After Surgery | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Assessing the Efficacy and Safety of Anti-HER2 Therapy in Nigerian Women With HER2+ Breast Cancer Before and After Surgery

Assessing the Efficacy and Safety of Optimal Neoadjuvant to Adjuvant Anti-HER2- Based Therapy in Nigerian Women With HER2+ Breast Cancer

NCT06348134•University of Chicago

View on ClinicalTrials.gov

Summary

Detailed Description

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. Participants with HER2-positive breast cancer will receive a combination of trastuzumab with pertuzumab (PHESGO) plus chemotherapy.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Written informed consent must be obtained prior to any screening procedures
•1. Women ages of 18 to 70 years old
•2. Biopsy-accessible breast tumor of significant size for core needle biopsy /ultrasound measurable (≥ 2cm)
•3. Measurable breast tumour using ultrasonography (≥ 2cm)
•4. Patients with histologically confirmed carcinoma of the female breast with positive HER2 status
•5. Clinical stages 2A -3C. (AJCC 2009)
•6. Chemotherapy-naïve patients (for this malignancy)
•7. Performance status: Eastern Cooperative Oncology Group performance status 0-3
•8. Non-pregnant and not nursing. Women of childbearing potential must take the pregnancy test and must commit to receive hormone therapy with Zoladex (goserelin) for two years starting from the commencement of the study medications
•9. Required Initial Laboratory Data. Adequate hematologic, renal and hepatic function, as defined by each of the following:
+1 more criteria

Exclusion Criteria

•Patients eligible for this study must not meet any of the following criteria:
•1. Pregnant or lactating women. Women of childbearing potential not using a reliable and appropriate contraceptive method. Postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential. Patients will agree to continue the use of acceptable form of contraception for 7 months from the date of last drug administration (Herceptin).
•2. Patients with distant metastasis
•3. Serious, uncontrolled, concurrent infection(s).
•4. Patients who have received more than 4 weeks of tamoxifen therapy for this malignancy. Patient who have received tamoxifen or raloxifene for purposes of chemoprevention (e.g. Breast Cancer Prevention Trial or for other past indications (including previous breast cancer) are eligible. Tamoxifen or raloxifene therapy will be discontinued at least one month before the patient is enrolled on this study.
•5. Treatment for other carcinomas within the last 5 years, except non-melanoma skin cancer and treated cervical carcinoma in-situ (CCIS)
•6. Participation in any investigational drug study within 4 weeks preceding the start of study treatment
•7. Other serious uncontrolled medical conditions that the investigator feels might compromise study participation including but not limited to chronic or active infection, HIV-positive patient, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled Diabetes mellitus, or psychiatric illness/social situations that would limit compliance with study requirements.
•8. Unwillingness to participate or inability to comply with the protocol for the duration of the study
•9. Patients with human epidermal growth factor receptor 2 (HER2-negative) disease
+4 more criteria

Locations (4)

Lagos State University Teaching Hospital

Ikeja, Lagos, Nigeria

Lagos University Teaching Hospital

Yaba, Lagos, Nigeria

Obafemi Awolowo University Teaching Hospitals Complex (OAUTHC)

Ile-Ife, Osun State, Nigeria

University of Ibadan Hospital

Ibadan, Oyo State, Nigeria

Key Dates

Start Date

March 18, 2025

Primary Completion Date

July 1, 2034

Completion Date

July 1, 2036

Last Updated

February 17, 2026

Enrollment

ESTIMATED participants

Conditions

Human Epidermal Growth Factor 2 Negative Carcinoma of BreastHER2-positive Breast CancerBreast Cancer

Interventions

Trastuzumab emtansine

DRUG

Pertuzumab Injection

DRUG

Docetaxel

DRUG

Tamoxifen

DRUG

Letrozole

DRUG

Goserelin

DRUG

Contacts

Olufunmilayo Olopade

CONTACT

(773) 702-1632 folopade@medicine.bsd.uchicago.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Assessing the Efficacy and Safety of Anti-HER2 Therapy in Nigerian Women With HER2+ Breast Cancer Before and After Surgery

Inclusion Criteria

Exclusion Criteria

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Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

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