Randomized Trial of Neo-adjuvant Chemotherapy With or Without Metformin for HER2 Positive Operable Breast Cancer
NCT ID: NCT03238495
Last Updated: 2021-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
100 participants
INTERVENTIONAL
2017-08-15
2023-06-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Chemotherapy Only
Taxotere, Carboplatin, Herceptin + Pertuzumab (TCH+P)
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)
Chemotherapy plus Metformin
TCH+P plus metformin
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)
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.
Interventions
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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)
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.
Eligibility Criteria
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Inclusion Criteria
* Unilateral or bilateral primary carcinoma of the breast, confirmed histologically by needle core biopsy. Fine-needle aspiration is not sufficient. Incisional/excisional biopsy is not allowed. In case of bilateral cancer, the investigator has to decide prospectively which side will be evaluated for the primary endpoint.
* Study participants must be cT1c - cT4a-d, any node (N), no metastases (M0). Any tumor (T) is allowed if node positive (biopsy proven and HER2 positive) including no primary invasive cancer or only ductal carcinoma in situ (DCIS). Metastatic workup is not required.
* Breast tumor must be \>1.5 cm in maximum diameter by clinical or any radiologic measurement, if node negative. If node is positive by biopsy, study participant will be eligible regardless of the size of the breast primary. In case of inflammatory breast cancer, the extent of inflammation/erythema can be used as measurable lesion.
* Multifocal or multicentric breast cancer is allowed if all the lesions are biopsied and are HER2 positive. Largest lesion will be assigned the target lesion.
* Must be HER2-positive in primary breast tumor or lymph node by the ASCO/CAP guidelines 2013: http://www.asco.org/guidelines/her2
* Ejection fraction (EF) greater than 50% by MUGA or ECHO within 4 weeks prior to first dose of study treatment.
* No prior cancer chemotherapy allowed.
* Adequate organ and marrow function as defined below, unless deemed non-clinically significant and approved by the Principal Investigator:
* Absolute neutrophil count ≥ 1,500/mcL
* Platelets ≥ 100,000/mcl
* total bilirubin within normal institutional limits
* AST(SGOT) ≤ 2.5 X institutional upper limit of normal
* ALT(SPGT) ≤ 2.5 X institutional upper limit of normal
* ALK Phos ≤ 2.5 X institutional upper limit of normal
* Creatinine clearance \> 50mL/min
* Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.
* Negative pregnancy test within 14 days prior to randomization
Exclusion Criteria
* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the study participant or the quality of the study data.
* Current or anticipated use of other investigational agents.
* Prior chemotherapy for any malignancy.
* Prior radiation therapy for breast cancer
* Previous malignant disease being disease-free for less than 5 years (except carcinoma in situ (CIS) of the cervix and non-melanoma skin cancer).
* Patients with diabetes on metformin. Patients with diabetes and not on metformin will be eligible if it is deemed safe after consultation with the patient physician managing diabetes.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to metformin or other agents used in study.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
18 Years
FEMALE
No
Sponsors
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Qamar Khan
OTHER
Responsible Party
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Qamar Khan
Associate Professor
Principal Investigators
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Qamar Khan, MD
Role: PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center
Locations
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The University of Kansas Cancer Center, West Clinic
Kansas City, Kansas, United States
The University of Kansas Cancer Center, Westwood Campus
Kansas City, Kansas, United States
The University of Kansas Cancer Center, Overland Park Clinic
Overland Park, Kansas, United States
The University of Kansas Cancer Center, South Clinic
Kansas City, Missouri, United States
The University of Kansas Cancer Center, North Clinic
Kansas City, Missouri, United States
The University of Kansas Cancer Center, Lee's Summit Clinic
Lee's Summit, Missouri, United States
Countries
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Central Contacts
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Facility Contacts
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Clinical Trials Nurse Navigator
Role: primary
Clinical Trials Nurse Navigator
Role: primary
Clinical Trials Nurse Navigator
Role: primary
Clinical Trials Nurse Navigator
Role: primary
Clinical Trials Nurse Navigator
Role: primary
Clinical Trials Nurse Navigator
Role: primary
Other Identifiers
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STUDY00140673
Identifier Type: -
Identifier Source: org_study_id