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

NCT06348134 | Recruiting Phase 2 DMC

• 1 other identifier: IRB23-0502
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

HER2-positive Breast Cancer; Breast Cancer; Human Epidermal Growth Factor 2 Negative Carcinoma of Breast

Outcome Measures

Primary Outcomes (1)

• Pathological Complete Response

  Pathological complete response of giving three-weekly docetaxel + subcutaneous trastuzumab and Pertuzumab with Tamoxifen/Letrozole added ) to Nigerian women with Human epidermal growth factor receptor 2 (HER2-positive) breast cancer as assessed by the absence of invasive neoplastic cells at microscopic examination of the primary tumor and lymph nodes at surgery.

  10 years

Secondary Outcomes (5)

• Reported Adverse Events and clinical/medical records of participants

  10 years

• Percentage of participants who are suitable for breast-conserving surgery

  10 years

• Event-free survival duration reported among participants

  10 years

• Quality of life reported among study participants

  10 years

• Genetic and epigenetic factors associated with breast cancer in Nigeria

  10 years

Study Arms (3)

Phase 1: All Participants

EXPERIMENTAL

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.

Drug: Trastuzumab emtansine; Drug: Pertuzumab Injection; Drug: Docetaxel

Phase 2 - Operable (participants who are able to have surgery)

EXPERIMENTAL

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.

Drug: Trastuzumab emtansine; Drug: Pertuzumab Injection; Drug: Docetaxel; Drug: Tamoxifen; Drug: Letrozole; Drug: Goserelin

Phase 2 - Inoperable (participants who are not able to have surgery)

EXPERIMENTAL

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.

Drug: Trastuzumab emtansine

Interventions

Trastuzumab emtansine DRUG

A chemotherapy drug.

Also known as: Kadcyla, T-DMI

Phase 1: All Participants; Phase 2 - Inoperable (participants who are not able to have surgery); Phase 2 - Operable (participants who are able to have surgery)

Pertuzumab Injection DRUG

A prescription medicine that is approved for use in combination with trastuzumab and docetaxel in people who have HER2-positive breast cancer that has spread to different parts of the body (metastatic) and who have not received anti-HER2 therapy or chemotherapy for metastatic breast cancer.

Also known as: Perjeta

Phase 1: All Participants; Phase 2 - Operable (participants who are able to have surgery)

Docetaxel DRUG

A chemotherapy drug.

Also known as: Taxotere, Docefrez

Phase 1: All Participants; Phase 2 - Operable (participants who are able to have surgery)

Tamoxifen DRUG

A medication used to treat breast cancer.

Also known as: Soltamox

Phase 2 - Operable (participants who are able to have surgery)

Letrozole DRUG

A medication used to treat breast cancer.

Phase 2 - Operable (participants who are able to have surgery)

Goserelin DRUG

A hormone therapy drug.

Also known as: Zoladex

Phase 2 - Operable (participants who are able to have surgery)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Breast cancer study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent must be obtained prior to any screening procedures
• Women ages of 18 to 70 years old
• Biopsy-accessible breast tumor of significant size for core needle biopsy /ultrasound measurable (≥ 2cm)
• Measurable breast tumour using ultrasonography (≥ 2cm)
• Patients with histologically confirmed carcinoma of the female breast with positive HER2 status
• Clinical stages 2A -3C. (AJCC 2009)
• Chemotherapy-naïve patients (for this malignancy)
• Performance status: Eastern Cooperative Oncology Group performance status 0-3
• 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
• Required Initial Laboratory Data. Adequate hematologic, renal and hepatic function, as defined by each of the following:
• \. Granulocyte ≥ 1,500/mL 2. Platelet count ≥ 100,000/mL 3. Absolute neutrophil count ≥ l500/mL 4. Hemoglobin 10g/dL 5. Bilirubin ≤ 1.5 x upper limit of normal 6. serum glutamic-oxaloacetic transaminase (SGOT) and Serum glutamic pyruvic transaminase (SGPT) \< 2.5 x upper limit of normal for patients without liver metastases 7. Creatinine within institutional normal limits or glomerular filtration rate ≥ 30 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration equation (see http://mdrd.com/ for calculator) 8. Echocardiogram: Baseline left ventricular ejection fraction of ≥ 55%

You may not qualify if:

• Patients eligible for this study must not meet any of the following criteria:
• 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).
• Patients with distant metastasis
• Serious, uncontrolled, concurrent infection(s).
• 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.
• Treatment for other carcinomas within the last 5 years, except non-melanoma skin cancer and treated cervical carcinoma in-situ (CCIS)
• Participation in any investigational drug study within 4 weeks preceding the start of study treatment
• 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.
• Unwillingness to participate or inability to comply with the protocol for the duration of the study
• Patients with human epidermal growth factor receptor 2 (HER2-negative) disease
• History of documented heart failure or systolic dysfunction (LVEF \< 50%), High-risk uncontrolled arrhythmias ie, atrial tachycardia with a heart rate \> 100/min at rest, significant ventricular arrhythmia (ventricular tachycardia) or higher-grade Atrioventricular (AV)-block (second degree AV-block Type 2 \[Mobitz 2\] or third degree AV-block),
• Angina pectoris requiring anti-anginal medication,
• Clinically significant valvular heart disease
• Poorly controlled hypertension (eg, systolic \> 180 mm Hg or diastolic \> 100 mm Hg)

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (4)

Lagos State University Teaching Hospital

Ikeja, Lagos, 100271, Nigeria

RECRUITING

Lagos University Teaching Hospital

Yaba, Lagos, 100254, Nigeria

RECRUITING

Obafemi Awolowo University Teaching Hospitals Complex (OAUTHC)

Ile-Ife, Osun State, 220005, Nigeria

RECRUITING

University of Ibadan Hospital

Ibadan, Oyo State, 200285, Nigeria

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Ado-Trastuzumab Emtansine; pertuzumab; Docetaxel; Tamoxifen; Letrozole; Goserelin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Maytansine; Macrolides; Lactones; Organic Chemicals; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Trastuzumab; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Nitriles; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Oligopeptides; Nerve Tissue Proteins

Study Officials

• Olufunmilayo Olopade

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olufunmilayo Olopade

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 4, 2024
• Study Start: March 18, 2025
• Primary Completion (Estimated): July 1, 2034
• Study Completion (Estimated): July 1, 2036
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

NG (4)