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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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:

⁃ 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%

Locations
Other Locations
Nigeria
University of Ibadan Hospital
RECRUITING
Ibadan
Lagos State University Teaching Hospital
RECRUITING
Ikeja
Obafemi Awolowo University Teaching Hospitals Complex (OAUTHC)
RECRUITING
Ile-ife
Lagos University Teaching Hospital
RECRUITING
Yaba
Contact Information
Primary
Olufunmilayo Olopade
folopade@medicine.bsd.uchicago.edu
(773) 702-1632
Time Frame
Start Date: 2025-03-18
Estimated Completion Date: 2036-07-01
Participants
Target number of participants: 74
Treatments
Experimental: Phase 1: All Participants
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.
Experimental: Phase 2 - Operable (participants who are able to have surgery)
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.
Experimental: Phase 2 - Inoperable (participants who are not able to have surgery)
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.
Sponsors
Leads: University of Chicago

This content was sourced from clinicaltrials.gov