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Monoclonal Antibodies
Phase 1: All Participants for Breast Cancer
Phase 2
Waitlist Available
Led By Olufunmilayo Olopade
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights
Study Summary
"This trial aims to study the effectiveness and safety of a specific cancer treatment for Nigerian women with breast cancer based on their HER2 status before and after surgery."
Who is the study for?
This trial is for Nigerian women with a type of breast cancer that tests positive for HER2, which means the cancer grows in response to a certain protein. Participants should be preparing for or have completed surgery and are now considering further treatment.Check my eligibility
What is being tested?
The study is testing how effective and safe anti-HER2 therapies like Tamoxifen, Docetaxel, Goserelin, Trastuzumab emtansine, Letrozole, and Pertuzumab Injection are when given before and after surgery to treat HER2+ breast cancer.See study design
What are the potential side effects?
Possible side effects from these treatments may include hot flashes or sweats (Tamoxifen), hair loss or nausea (Docetaxel), changes in menstrual cycle (Goserelin), liver issues or fatigue (Trastuzumab emtansine), bone pain (Letrozole), and infusion reactions (Pertuzumab).
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pathological Complete Response
Secondary outcome measures
Event-free survival duration reported among participants
Genetic and epigenetic factors associated with breast cancer in Nigeria
Percentage of participants who are suitable for breast-conserving surgery
+2 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Phase 2 - Operable (participants who are able to have surgery)Experimental Treatment6 Interventions
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.
Group II: Phase 2 - Inoperable (participants who are not able to have surgery)Experimental Treatment1 Intervention
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.
Group III: Phase 1: All ParticipantsExperimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Letrozole
2002
Completed Phase 4
~3240
Tamoxifen
2005
Completed Phase 4
~30070
Goserelin
2008
Completed Phase 3
~4110
Trastuzumab emtansine
2010
Completed Phase 4
~2220
Docetaxel
1995
Completed Phase 4
~5620
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,003 Previous Clinical Trials
819,675 Total Patients Enrolled
25 Trials studying Breast Cancer
4,685 Patients Enrolled for Breast Cancer
Olufunmilayo OlopadePrincipal InvestigatorUniversity of Chicago
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the recruitment for this research study presently ongoing?
"As per clinicaltrials.gov, the ongoing trial is not actively seeking participants. The study was initially uploaded on July 1st, 2024 and updated most recently on March 29th, 2024. While this particular trial isn't recruiting currently, it's noteworthy that there are a total of 2701 other trials actively looking for candidates."
Answered by AI
Has the FDA given its approval for all participants in Phase 1 of this study?
"In our assessment, the safety rating for Phase 1: All Participants is graded at a level of 2 due to being in Phase 2, where some safety data exists but efficacy data is lacking."
Answered by AI
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