Trials / Unknown
UnknownNCT03238495
Randomized Trial of Neo-adjuvant Chemotherapy With or Without Metformin for HER2 Positive Operable Breast Cancer
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Qamar Khan · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to determine the efficacy of metformin as a repurposed agent in human epidermal growth factor receptor 2 (HER2) positive breast cancer when added to standard neo-adjuvant chemotherapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Taxotere, Carboplatin, Herceptin + Pertuzumab | TCH+P chemotherapy every 3 weeks for 6 cycles: Taxotere 75mg/m2, Carboplatin AUC 6, Herceptin 6mg/kg (first cycle loading dose of 8mg/kg), Pertuzumab 420mg (first cycle loading does of 840mg) |
| DRUG | Metformin | TCH+P chemotherapy every 3 weeks for 6 cycles. Metformin 850 mg daily during the first cycle, then 850 mg twice daily for the remaining 5 cycles. |
Timeline
- Start date
- 2017-08-15
- Primary completion
- 2022-06-01
- Completion
- 2023-06-01
- First posted
- 2017-08-03
- Last updated
- 2021-12-07
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03238495. Inclusion in this directory is not an endorsement.