HER2-positive Breast CancerPhase 2HERMETNCT03238495
Randomized Trial of Neo-adjuvant Chemotherapy With or Without Metformin for HER2 Positive Operable Breast Cancer
A Phase 2 study testing Taxotere, Carboplatin, Herceptin + Pertuzumab and Metformin in people with HER2-positive Breast Cancer, run by Qamar Khan at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HER2-positive Breast Cancer
- What is being tested?
- Taxotere, Carboplatin, Herceptin + Pertuzumab and Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 6 sitesUnited States
- Study dates
- 15 Aug 2017to 1 Jun 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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).
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- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
The University of Kansas Cancer Center, West Clinic
Kansas City, Kansas, 66112
Clinical Trials Nurse Navigator, 913-945-7552, ctnursenav@kumc.edu
- Recruiting
The University of Kansas Cancer Center, Westwood Campus
Kansas City, Kansas, 66205
Clinical Trials Nurse Navigator, 913-945-7552, ctnursenav@kumc.edu
- Recruiting
The University of Kansas Cancer Center, South Clinic
Kansas City, Missouri, 64131
Clinical Trials Nurse Navigator, 913-945-7552, ctnursenav@kumc.edu
- Recruiting
The University of Kansas Cancer Center, North Clinic
Kansas City, Missouri, 64154
Clinical Trials Nurse Navigator, 913-945-7552, ctnursenav@kumc.edu
- Recruiting
The University of Kansas Cancer Center, Lee's Summit Clinic
Lee's Summit, Missouri, 64064
Clinical Trials Nurse Navigator, 913-945-7552, ctnursenav@kumc.edu
- Recruiting
The University of Kansas Cancer Center, Overland Park Clinic
Overland Park, Kansas, 66210
Clinical Trials Nurse Navigator, 913-945-7552, ctnursenav@kumc.edu
About this study
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
- HER2-positive Breast Cancer
- Being tested
- Taxotere, Carboplatin, Herceptin + Pertuzumab, Metformin
- Keywords
- Operable breast cancer, Neo-adjuvant chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taxotere, Carboplatin, Herceptin + PertuzumabDrug
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)
MetforminDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy Only | Active comparator | Taxotere, Carboplatin, Herceptin + Pertuzumab (TCH+P) Receives: Drug: Taxotere, Carboplatin, Herceptin + Pertuzumab |
| Chemotherapy plus Metformin | Experimental | TCH+P plus metformin Receives: Drug: Taxotere, Carboplatin, Herceptin + Pertuzumab; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic complete response (pCR)
pCR at surgery
Measured: Up to 6 weeks after last chemotherapy treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start15 Aug 2017
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qamar Khan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qamar Khan, University of Kansas Medical Center
- Investigators
- Qamar Khan, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03238495
- Sponsor's protocol ID
- STUDY00140673
- Acronym
- HERMET
- Status last verified
- Dec 2021
- First submitted
- 31 Jul 2017
- Last updated
- 7 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Neo-adjuvant Chemotherapy With or Without Metformin for HER2 Positive Operable Breast Cancer
- ClinicalTrials.gov ID
- NCT03238495
- Acronym / sponsor ID
- HERMET / STUDY00140673
- Conditions
- HER2-positive Breast Cancer
- Keywords
- Operable breast cancer, Neo-adjuvant chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Qamar KhanUniversity, hospital or other
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 3 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy Only | Active comparator | Drug: Taxotere, Carboplatin, Herceptin + PertuzumabTaxotere, Carboplatin, Herceptin + Pertuzumab (TCH+P) |
| Chemotherapy plus Metformin | Experimental | Drug: Taxotere, Carboplatin, Herceptin + Pertuzumab, Drug: MetforminTCH+P plus metformin |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Taxotere, Carboplatin, Herceptin + PertuzumabTCH+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 | Chemotherapy Only, Chemotherapy plus Metformin |
| MetforminTCH+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. | Drug | Chemotherapy plus Metformin |
Primary outcome
Pathologic complete response (pCR)
Time frame: Up to 6 weeks after last chemotherapy treatment
pCR at surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qamar Khan, MD principal investigator
University of Kansas Medical Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Taxotere, Carboplatin, Herceptin + Pertuzumab and Metformin in people with HER2-positive Breast Cancer, run by Qamar Khan at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Nurse Navigator (913-945-7552, ctnursenav@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic complete response (pCR) (time frame: Up to 6 weeks after last chemotherapy treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2021.