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Trial record 18 of 175 for:    The University of Kansas Cancer Center | Recruiting, Not yet recruiting, Available Studies

Randomized Trial of Neo-adjuvant Chemotherapy With or Without Metformin for HER2 Positive Operable Breast Cancer (HERMET)

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ClinicalTrials.gov Identifier: NCT03238495
Recruitment Status : Recruiting
First Posted : August 3, 2017
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Qamar Khan, University of Kansas Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
HER2-positive Breast Cancer Drug: Taxotere, Carboplatin, Herceptin + Pertuzumab Drug: Metformin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial of Neo-adjuvant Chemotherapy With or Without Metformin for HER2 Positive Operable Breast Cancer
Actual Study Start Date : August 2, 2017
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: Chemotherapy Only
Taxotere, Carboplatin, Herceptin + Pertuzumab (TCH+P)
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)

Experimental: Chemotherapy plus Metformin
TCH+P plus metformin
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.




Primary Outcome Measures :
  1. Pathologic complete response (pCR) [ Time Frame: Up to 6 weeks after last chemotherapy treatment ]
    pCR at surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1.
  • 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:

  • Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03238495


Contacts
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Contact: Clinical Trials Nurse Navigator 913-945-7552 ctnursenav@kumc.edu

Locations
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United States, Kansas
The University of Kansas Cancer Center, West Clinic Recruiting
Kansas City, Kansas, United States, 66112
Contact: Clinical Trials Nurse Navigator    913-945-7552    ctnursenav@kumc.edu   
The University of Kansas Cancer Center, Westwood Campus Recruiting
Kansas City, Kansas, United States, 66205
Contact: Clinical Trials Nurse Navigator    913-945-7552    ctnursenav@kumc.edu   
The University of Kansas Cancer Center, Overland Park Clinic Recruiting
Overland Park, Kansas, United States, 66210
Contact: Clinical Trials Nurse Navigator    913-945-7552    ctnursenav@kumc.edu   
United States, Missouri
The University of Kansas Cancer Center, South Clinic Recruiting
Kansas City, Missouri, United States, 64131
Contact: Clinical Trials Nurse Navigator    913-945-7552    ctnursenav@kumc.edu   
The University of Kansas Cancer Center, North Clinic Recruiting
Kansas City, Missouri, United States, 64154
Contact: Clinical Trials Nurse Navigator    913-945-7552    ctnursenav@kumc.edu   
The University of Kansas Cancer Center, Lee's Summit Clinic Recruiting
Lee's Summit, Missouri, United States, 64064
Contact: Clinical Trials Nurse Navigator    913-945-7552    ctnursenav@kumc.edu   
Sponsors and Collaborators
Qamar Khan
Investigators
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Principal Investigator: Qamar Khan, MD University of Kansas Medical Center

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Responsible Party: Qamar Khan, Associate Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03238495     History of Changes
Other Study ID Numbers: STUDY00140673
First Posted: August 3, 2017    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Qamar Khan, University of Kansas Medical Center:
Operable breast cancer
Neo-adjuvant chemotherapy

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Metformin
Carboplatin
Docetaxel
Trastuzumab
Pertuzumab
Hypoglycemic Agents
Physiological Effects of Drugs
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological