Locally Advanced Malignant NeoplasmPhase 2NCT01566799
Metformin Plus Neoadjuvant Chemotherapy in Breast Cancer
A Phase 2 study testing Metformin in people with Locally Advanced Malignant Neoplasm, run by Instituto Nacional de Cancerologia de Mexico at 1 site in Mexico.
Trial summary
Background Obesity and overweight are well known risk factors for breast cancer and also are associated with higher recurrence and mortality rates. Main goal of this study is to evaluate the efficacy of metformin plus chemotherapy in terms of pathologic complete response in comparison with placebo plus the same… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Locally Advanced Malignant Neoplasm
- What is being tested?
- Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMexico
- Study dates
- Apr 2012to Apr 2014
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women older than 18 years old and younger than 70 years old
- Invasive breast cancer confirmed by core biopsy, any histology
- Tumor ≥2 cm and/or lymph node positive (proven by FNA)(T2-4b, N0-3, M0)
- Must have ER/PR positive and HER2 negative
- Must have full staging and extent disease and clinically and radiographically tumor measure
- Without previous treatment for breast cancer (including surgery, hormonotherapy or chemotherapy)
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- Normal liver, kidney and blood tests
- Performance Status ECOG 0-2 o Karnofsky ≥70%
- Fasten glucose levels <125 mg/dl
- Signed consent
Who cannot join
- Previous use of metformin for any indication
- Presence of Diabetes Mellitus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Phase II, Randomized, Double Blind Trial, to Evaluate the Efficacy of Metformin and Chemotherapy Versus Placebo Nad Chemotherapy in Neoadjuvant Setting for Locally Advanced Breast Cancer
Background Obesity and overweight are well known risk factors for breast cancer and also are associated with higher recurrence and mortality rates.
Main goal of this study is to evaluate the efficacy of metformin plus chemotherapy in terms of pathologic complete response in comparison with placebo plus the same chemotherapy regimen Design: Randomized, double blind, clinical trial. This study will be performed at National Cancer Institute of Mexico City, at breast cancer unit.
Read more
Patients with ER+ or PR+, HER2 negative, breast cancer are candidates to participate.
After completion of chemotherapy all patients will have a breast surgery to assess pathologic response.
Complete pathologic response is defined as the abscence of malignant cells in breast tissue and lymph nodes. The presence of DCIS is considered as pCR
Read the detailed description
Definitions Luminal A: tumors ER + PR + HER2 Negative and Ki67 <14% Luminal B: tumors ER +/-, PR +/-, HER2 negative and Ki67 >15% Complete pathologic response is defined as the abscence of malignant cells in breast tissue and lymph nodes. The presence of DCIS is considered as pCR
- Conditions
- Locally Advanced Malignant Neoplasm
- Being tested
- Metformin
- Keywords
- Locally advanced breast cancer, Neoadjuvant chemotherapy, Metformin, Pathologic Complete Response
- Medical subject headings
- Pathologic Complete Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Dabex
metformin 500 mg/day po for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Experimental | Patients will be receive 12 weeks of paclitaxel followed by 4 cycles of FAC combined with 500 mg/day of metformin p.o. Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathologic complete response
to assess the efficacy in terms of pahtologic complete response in patients with locally advanced breast cancer, treated with neoadjuvant chemotherapy based on Paclitaxel followed by FAC, combined with metformin or placebo
Measured: pCR will be assesed after 24 weeks of treatment
Secondary outcomes (3)
Safety analysis
For safety analysis we are going to use NCTC criteria version 3.0
Measured: after 24 treatment weeks'
Assess clinical response at the end of paclitaxel and at the end of neoadjuvant chemotherapy
tumor measurements by caliper every cycle and by ultrasound at the end of chemotherapy
Measured: after 24 treatment weeks'
To correlate serum levels of insulin, protein C and HbA1 (after treatment) with clinical and pathologic response
correlation between serum levels of insuline levels, HbA1 and PCR and PCR
Measured: safter 24 treatment weeks'
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionApr 2013 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Malignant NeoplasmStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cancerologia de Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Responsible party
- Principal investigator, Claudia Arce Salinas, Instituto Nacional de Cancerologia de Mexico
- Investigators
- Claudia Arce, MD, MSc, Principal investigator, Instituto Nacional Canerologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01566799
- Sponsor's protocol ID
- MET-INCAN-1
- Status last verified
- Mar 2012
- First submitted
- 22 Mar 2012
- Last updated
- 30 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Phase II, Randomized, Double Blind Trial, to Evaluate the Efficacy of Metformin and Chemotherapy Versus Placebo Nad Chemotherapy in Neoadjuvant Setting for Locally Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT01566799
- Acronym / sponsor ID
- MET-INCAN-1
- Conditions
- Locally Advanced Malignant Neoplasm
- Keywords
- Locally advanced breast cancer, Neoadjuvant chemotherapy, Metformin, Pathologic Complete Response
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Instituto Nacional de Cancerologia de MexicoUniversity, hospital or other
- Collaborators
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Study start
- Apr 2012
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 29 Mar 2012 (estimated)
- 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.
Background Obesity and overweight are well known risk factors for breast cancer and also are associated with higher recurrence and mortality rates.
Main goal of this study is to evaluate the efficacy of metformin plus chemotherapy in terms of pathologic complete response in comparison with placebo plus the same chemotherapy regimen Design: Randomized, double blind, clinical trial. This study will be performed at National Cancer Institute of Mexico City, at breast cancer unit.
Patients with ER+ or PR+, HER2 negative, breast cancer are candidates to participate.
After completion of chemotherapy all patients will have a breast surgery to assess pathologic response.
Complete pathologic response is defined as the abscence of malignant cells in breast tissue and lymph nodes. The presence of DCIS is considered as pCR
Detailed description
Definitions Luminal A: tumors ER + PR + HER2 Negative and Ki67 <14% Luminal B: tumors ER +/-, PR +/-, HER2 negative and Ki67 >15% Complete pathologic response is defined as the abscence of malignant cells in breast tissue and lymph nodes. The presence of DCIS is considered as pCR
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metformin | Experimental | Drug: MetforminPatients will be receive 12 weeks of paclitaxel followed by 4 cycles of FAC combined with 500 mg/day of metformin p.o. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Women older than 18 years old and younger than 70 years old
- Normal liver, kidney and blood tests
- Performance Status ECOG 0-2 o Karnofsky ≥70%
- Fasten glucose levels <125 mg/dl
- Signed consent
Key exclusion criteria (2 listed)
- Previous use of metformin for any indication
- Presence of Diabetes Mellitus
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 |
|---|---|---|
| MetforminAlso: Dabexmetformin 500 mg/day po for 24 weeks. | Drug | Metformin |
Primary outcome
pathologic complete response
Time frame: pCR will be assesed after 24 weeks of treatment
to assess the efficacy in terms of pahtologic complete response in patients with locally advanced breast cancer, treated with neoadjuvant chemotherapy based on Paclitaxel followed by FAC, combined with metformin or placebo
3 secondary outcomes
Safety analysis
Time frame: after 24 treatment weeks'
Assess clinical response at the end of paclitaxel and at the end of neoadjuvant chemotherapy
Time frame: after 24 treatment weeks'
To correlate serum levels of insulin, protein C and HbA1 (after treatment) with clinical and pathologic response
Time frame: safter 24 treatment weeks'
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2012.
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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.
Claudia Arce, MD, MSc principal investigator
Instituto Nacional Canerologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin in people with Locally Advanced Malignant Neoplasm, run by Instituto Nacional de Cancerologia de Mexico at 1 site in Mexico.
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 10 inclusion and 2 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 30 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. 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 Claudia Arce, MD, MSc (+525556280400 ext. 294, haydee.arce96@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathologic complete response (time frame: pCR will be assesed after 24 weeks of 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 30 Mar 2012.