pCR RatePhase 2NeoMETNCT01929811
NeoMET Study in Neoadjuvant Treatment of Breast Cancer
A Phase 2 study testing Metformin, Docetaxel and Epirubicin in people with pCR Rate and BCT Rate, run by Shanghai Jiao Tong University School of Medicine at 2 sites in China.
Trial summary
To evaluate docetaxel, epirubicin and cyclophosphomide (TEC) with TEC plus metformin in neoadjuvant treatment of breast cancer patients. The aim is to evaluate whether metformin can increase the pCR rate combination with TEC regimen in neoadjuvant setting. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- What is being tested?
- Metformin, Docetaxel and Epirubicin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 2 sitesChina
- Study dates
- Oct 2013to Jun 2020
- 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 aged ≥18 years and < 70 years with life expectancy > 12 months
- Measurable disease in breast or axillary lymph node, histologically confirmed invasive breast cancer by core needle biopsy, T≥2cm or stage IIb or stage III according AJCC classification, fine-needle aspiration is encouraged to every patient with metastasis suspicious nodes;
- Biopsy specimens are available for ER, PgR, Her2 and proliferation biomarker detection;
- Adequate bone marrow function: Neutrophil ≥ 1.5*109/L; Hb ≥ 100g/L; PLT ≥ 80*109/L;
- Adequate liver and renal function:
- Serum AST ≤ 90U/L
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- Bilirubin ≤ upper limit of normal (UNL) range
- Serum creatinine ≤110 umol/L，calculated creatinine clearance should be ≥ 60 mL/min;
- BUN ≤ 7.1mmol/L;
- Has ECOG Performance Score 0-1;
- BMI ≥ 25kg/m2 or hyperglycemia or hyperlipemia or hypertension;
- Willing to take biopsy before neoadjuvant chemotherapy and patients must be accessible for treatment and follow-up;
- Women with potential child-bearing must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to use an acceptable method of birth control to avoid pregnancy for the duration of the study;
- Written informed consent according to the local ethics committee requirements.
Who cannot join
- Prior systemic or loco-regional treatment of breast cancer, including chemotherapy;
- Metastatic breast cancer;
- With a history of malignant tumor except uterine cervix cancer in situ or skin basal cell carcinoma;
- Patients with medical conditions that indicate intolerant to neoadjuvant therapy and related treatment, including uncontrolled pulmonary disease, severe infection, active peptic ulcer, coagulation disorder, connective tissue disease or myelo-suppressive disease;
- Has active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) or is known to be HIV positive;
- Contraindication for using dexamethasone, chemotherapy agents or metformin;
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- History of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction; poorly controlled hypertension (systolic BP >180mmHg or diastolic BP >100mmHg);
- Has peripheral neuropathy ≥ grade 1;
- Patient is pregnant or breast feeding (not willing to stop breast feeding);
- Not willing to take core needle biopsy or patients with psychiatric disorder or other diseases leading to incompliance to the therapy
- Known severe hypersensitivity to any drugs in this study;
- Treatment with any investigational drugs within 30 days before the beginning of study treatment.
- History of lactic or other metabolic acidosis
- Consumption of > 3 alcoholic beverages per day (on average)
Trial locations and contacts
2 sites in 1 country.
China2 sites
Linyi People's Hospital
Linyi, Shandong, 276003
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
About this study
Official title: Neoadjuvant Treatment of TEC Versus TEC Plus Metformin in Breast Cancer：A Prospective, Randomized Trial
To evaluate docetaxel, epirubicin and cyclophosphomide (TEC) with TEC plus metformin in neoadjuvant treatment of breast cancer patients. The aim is to evaluate whether metformin can increase the pCR rate combination with TEC regimen in neoadjuvant setting.
Read the detailed description
Neoadjuvant therapy is the standard treatment for locally advanced breast cancer and has adopted in early breast cancer treatment. A meta-analysis showed no difference between neoadjuvant therapy and adjuvant therapy in terms of survival and overall disease progression. Therefore, neoadjuvant treatment can be offered as a standard treatment and as an alternative to adjuvant treatment to all patients who are expected to be candidates for adjuvant systemic chemotherapy. Patients achieved pCR after treatment have superior outcome.
The taxanes were introduced into clinical practice in the early 1990s, and recent meta-analysis showed that compared with anthracycline-containing chemotherapy, taxanes-containing regimens significantly reduced the annual breast cancer recurrences and deaths. Right now, TAC regimen has widely accepted as adjuvant or neoadjuvant chemotherapy regimens in breast cancer treatment.
Metformin, an inexpensive oral agent commonly used to treat type 2 diabetes, has been garnering increasing attention as a potential anti-cancer agent. In neoadjuvant treatment of breast cancer, a retrospective clinical study from MDACC reported a significantly increased pCR rates to standard neoadjuvant chemotherapy in diabetic breast cancer patients who were receiving metformin (24% pCR) compared to diabetics not receiving metformin (8% pCR), with intermediate rates in non-diabetics who did not receive metformin (16% pCR), indicating metformin may increase pCR rate with neoadjuvant chemotherapy.
Base on these data, we initiate a prospective study to evaluate docetaxel, epirubicin and cyclophosphomide (TEC) with TEC plus metformin in neoadjuvant treatment of breast cancer patients. Our aim is to evaluate whether metformin can increase the pCR rate combination with TEC regimen in neoadjuvant setting.
- Being tested
- Metformin, Docetaxel, Epirubicin, cyclophosphomide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Metformin HCL, Metformin hydroehloride
Metformin: 500mg tid, orally (500mg daily in first cycle) on day 1 to day 21 of each 21 day cycle
DocetaxelDrug
75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle; 6 cycles.
EpirubicinDrug
75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle; 6 cycles.
cyclophosphomideDrug
500 mg/m2, IV (in the vein) on day 1 of each 21 day cycle; 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Metformin arm | Experimental | Docetaxel: 75mg/m2, d1, q3w*6 Epirubicin: 75mg/m2, d1, q3w*6 Cyclophosphamide: 500mg/m2, d1, q3w*6 Metformin: 500mg tid, orally (500mg daily in first cycle) Receives: Drug: Metformin; Drug: Docetaxel; Drug: Epirubicin; Drug: cyclophosphomide |
| TEC | Other | Docetaxel: 75mg/m2, d1, q3w*6 Epirubicin: 75mg/m2, d1, q3w*6 Cyclophosphamide: 500mg/m2, d1, q3w*6 Receives: Drug: Docetaxel; Drug: Epirubicin; Drug: cyclophosphomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathologic complete response rate
To compare pathologic complete response (pCR) rate to neoadjuvant chemotherapy between Docetaxel, Epirubicin and Cyclophosphamide (TEC) arm and TEC plus Metformin arm in breast cancer.
Definition of pCR is no invasive tumor in primary breast and axillary lymph node.
Measured: 5 months
Secondary outcomes (3)
Clinical response rate
To compare the clinical response rate between Docetaxel, Epirubicin and Cyclophosphamide (TEC) arm and TEC plus Metformin arm in breast cancer neoadjuvant treatment.
Measured: up to 4.5 months
safety profile
To compare the tolerability and side effects of neoadjuvant chemotherapy between Docetaxel, Epirubicin and Cyclophosphamide (TEC) arm and TEC plus Metformin arm in breast cancer treatment.
Measured: up to 4.5 months
breast conservation therapy (BCT) rate
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2013 (estimated)
- Study startOct 2013
- Primary completionJun 2020
- Study completionJun 2020
Why it stopped: Slow enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for pCR RateStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kunwei Shen, Shanghai Jiao Tong University School of Medicine
- Investigators
- Kunwei Shen, Dr., Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01929811
- Sponsor's protocol ID
- RJBC1301
- Acronym
- NeoMET
- Status last verified
- Mar 2022
- First submitted
- 11 Aug 2013
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Huang J, Tong Y, Hong J, Huang O, Wu J, He J, Chen W, Li Y, Chen X, Shen K. Neoadjuvant docetaxel, epirubicin, and cyclophosphamide with or without metformin in breast cancer patients with metabolic abnormality: results from the randomized Phase II NeoMET trial. Breast Cancer Res Treat. 2023 Feb;197(3):525-533. doi: 10.1007/s10549-022-06821-y. Epub 2022 Dec 16.
PubMed 36525180
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Treatment of TEC Versus TEC Plus Metformin in Breast Cancer：A Prospective, Randomized Trial
- ClinicalTrials.gov ID
- NCT01929811
- Acronym / sponsor ID
- NeoMET / RJBC1301
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment.
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Oct 2013 (actual)
- Primary completion
- Jun 2020 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 28 Aug 2013 (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.
To evaluate docetaxel, epirubicin and cyclophosphomide (TEC) with TEC plus metformin in neoadjuvant treatment of breast cancer patients. The aim is to evaluate whether metformin can increase the pCR rate combination with TEC regimen in neoadjuvant setting.
Detailed description
Neoadjuvant therapy is the standard treatment for locally advanced breast cancer and has adopted in early breast cancer treatment. A meta-analysis showed no difference between neoadjuvant therapy and adjuvant therapy in terms of survival and overall disease progression. Therefore, neoadjuvant treatment can be offered as a standard treatment and as an alternative to adjuvant treatment to all patients who are expected to be candidates for adjuvant systemic chemotherapy. Patients achieved pCR after treatment have superior outcome.
The taxanes were introduced into clinical practice in the early 1990s, and recent meta-analysis showed that compared with anthracycline-containing chemotherapy, taxanes-containing regimens significantly reduced the annual breast cancer recurrences and deaths. Right now, TAC regimen has widely accepted as adjuvant or neoadjuvant chemotherapy regimens in breast cancer treatment.
Metformin, an inexpensive oral agent commonly used to treat type 2 diabetes, has been garnering increasing attention as a potential anti-cancer agent. In neoadjuvant treatment of breast cancer, a retrospective clinical study from MDACC reported a significantly increased pCR rates to standard neoadjuvant chemotherapy in diabetic breast cancer patients who were receiving metformin (24% pCR) compared to diabetics not receiving metformin (8% pCR), with intermediate rates in non-diabetics who did not receive metformin (16% pCR), indicating metformin may increase pCR rate with neoadjuvant chemotherapy.
Base on these data, we initiate a prospective study to evaluate docetaxel, epirubicin and cyclophosphomide (TEC) with TEC plus metformin in neoadjuvant treatment of breast cancer patients. Our aim is to evaluate whether metformin can increase the pCR rate combination with TEC regimen in neoadjuvant setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin arm | Experimental | Drug: Metformin, Drug: Docetaxel, Drug: Epirubicin, Drug: cyclophosphomideDocetaxel: 75mg/m2, d1, q3w*6 Epirubicin: 75mg/m2, d1, q3w*6 Cyclophosphamide: 500mg/m2, d1, q3w*6 Metformin: 500mg tid, orally (500mg daily in first cycle) |
| TEC | Other | Drug: Docetaxel, Drug: Epirubicin, Drug: cyclophosphomideDocetaxel: 75mg/m2, d1, q3w*6 Epirubicin: 75mg/m2, d1, q3w*6 Cyclophosphamide: 500mg/m2, d1, q3w*6 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- women aged ≥18 years and < 70 years with life expectancy > 12 months
- Measurable disease in breast or axillary lymph node, histologically confirmed invasive breast cancer by core needle biopsy, T≥2cm or stage IIb or stage III according AJCC classification, fine-needle aspiration is encouraged to every patient with metastasis suspicious nodes;
- Biopsy specimens are available for ER, PgR, Her2 and proliferation biomarker detection;
- Adequate bone marrow function: Neutrophil ≥ 1.5*109/L; Hb ≥ 100g/L; PLT ≥ 80*109/L;
- Adequate liver and renal function:
Key exclusion criteria (14 listed)
- Prior systemic or loco-regional treatment of breast cancer, including chemotherapy;
- Metastatic breast cancer;
- With a history of malignant tumor except uterine cervix cancer in situ or skin basal cell carcinoma;
- Patients with medical conditions that indicate intolerant to neoadjuvant therapy and related treatment, including uncontrolled pulmonary disease, severe infection, active peptic ulcer, coagulation disorder, connective tissue disease or myelo-suppressive disease;
- Has active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) or is known to be HIV positive;
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: Metformin HCL, Metformin hydroehlorideMetformin: 500mg tid, orally (500mg daily in first cycle) on day 1 to day 21 of each 21 day cycle | Drug | Metformin arm |
| Docetaxel75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle; 6 cycles. | Drug | Metformin arm, TEC |
| Epirubicin75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle; 6 cycles. | Drug | Metformin arm, TEC |
| cyclophosphomide500 mg/m2, IV (in the vein) on day 1 of each 21 day cycle; 6 cycles. | Drug | Metformin arm, TEC |
Primary outcome
pathologic complete response rate
Time frame: 5 months
To compare pathologic complete response (pCR) rate to neoadjuvant chemotherapy between Docetaxel, Epirubicin and Cyclophosphamide (TEC) arm and TEC plus Metformin arm in breast cancer. Definition of pCR is no invasive tumor in primary breast and axillary lymph node.
3 secondary outcomes
Clinical response rate
Time frame: up to 4.5 months
safety profile
Time frame: up to 4.5 months
breast conservation therapy (BCT) rate
Time frame: 5 months
Results and safety
The study was stopped early (reason given: Slow enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Derived from this study: PubMed 36525180Huang J, Tong Y, Hong J, Huang O, Wu J, He J, Chen W, Li Y, Chen X, Shen K. Neoadjuvant docetaxel, epirubicin, and cyclophosphamide with or without metformin in breast cancer patients with metabolic abnormality: results from the randomized Phase II NeoMET trial. Breast Cancer Res Treat. 2023 Feb;197(3):525-533. doi: 10.1007/s10549-022-06821-y. Epub 2022 Dec 16.
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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.
Kunwei Shen, Dr. principal investigator
Ruijin Hospital
2 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 Metformin, Docetaxel and Epirubicin in people with pCR Rate and BCT Rate, run by Shanghai Jiao Tong University School of Medicine at 2 sites in China.
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 14 inclusion and 14 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: stopped early, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
The study was stopped early (reason given: Slow enrollment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathologic complete response rate (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01929811, which also lists 1 linked publication.
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 6 Apr 2022.