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

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

NCT ID: NCT06348134

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

Conditions: Official terms:
Breast Neoplasms
Tamoxifen
Docetaxel
Trastuzumab
Letrozole
Pertuzumab
Goserelin
Maytansine
Ado-Trastuzumab Emtansine

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Crossover Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Trastuzumab emtansine
Description: A chemotherapy drug.
Arm group label: Phase 1: All Participants
Arm group label: Phase 2 - Inoperable (participants who are not able to have surgery)
Arm group label: Phase 2 - Operable (participants who are able to have surgery)

Other name: Kadcyla

Other name: T-DMI

Intervention type: Drug
Intervention name: Pertuzumab Injection
Description: 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.
Arm group label: Phase 1: All Participants
Arm group label: Phase 2 - Operable (participants who are able to have surgery)

Other name: Perjeta

Intervention type: Drug
Intervention name: Docetaxel
Description: A chemotherapy drug.
Arm group label: Phase 1: All Participants
Arm group label: Phase 2 - Operable (participants who are able to have surgery)

Other name: Taxotere

Other name: Docefrez

Intervention type: Drug
Intervention name: Tamoxifen
Description: A medication used to treat breast cancer.
Arm group label: Phase 2 - Operable (participants who are able to have surgery)

Other name: Soltamox

Intervention type: Drug
Intervention name: Letrozole
Description: A medication used to treat breast cancer.
Arm group label: Phase 2 - Operable (participants who are able to have surgery)

Intervention type: Drug
Intervention name: Goserelin
Description: A hormone therapy drug.
Arm group label: Phase 2 - Operable (participants who are able to have surgery)

Other name: Zoladex

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.

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.

Criteria for eligibility:
Criteria:
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. 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% 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 10. 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), 11. Angina pectoris requiring anti-anginal medication, 12. Clinically significant valvular heart disease 13. Poorly controlled hypertension (eg, systolic > 180 mm Hg or diastolic > 100 mm Hg)

Gender: Female

Gender based: Yes

Gender description: Breast cancer study.

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of Chicago

Address:
City: Chicago
Zip: 60615
Country: United States

Contact:
Last name: Olufunmilayo Olufunmilayo

Phone: 773-702-1632
Email: folopade@medicine.bsd.uchicago.edu

Start date: July 1, 2024

Completion date: July 1, 2036

Lead sponsor:
Agency: University of Chicago
Agency class: Other

Source: University of Chicago

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06348134