Safety Clinical Trial - NeoMET Study in Neoadjuvant Treatment of Breast

Status Terminated

Clinical 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01929811
Study type	Interventional
Source	Shanghai Jiao Tong University School of Medicine
Contact
Status	Terminated
Phase	Phase 2
Start date	October 2013
Completion date	June 2020

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05073744` - Nalbuphine Versus Morphine for Perioperative Tumor Ablation	Phase 4
Completed	`NCT03969641` - Safety of RIV4 Versus IIV4 in Pregnant Women	Phase 4
Completed	`NCT05592951` - Safety and Tolerability of a Novel Amino-acid Based Hydration Drink in Healthy Volunteers	N/A
Completed	`NCT04693429` - Clinical Study for the Evaluation of Safety and Tolerability of PRO-172 Ophthalmic Solution+	Phase 1
Completed	`NCT01636024` - To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Doses of Inhaled AZD7594	Phase 1
Completed	`NCT01415102` - A First In Human Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Single Inhaled Doses Of PF-05212372.	Phase 1
Completed	`NCT01243502` - A Study to Assess the Pharmacokinetics, Safety and Tolerability of CT327 in Healthy Male Volunteers	Phase 1
Completed	`NCT06072170` - Single Ascending Doses of Kratom in Healthy Nondependent Adults With Opioid Experience	Phase 1
Completed	`NCT05076253` - Efficacy of Ivermectin in COVID-19	Phase 1/Phase 2
Recruiting	`NCT06060379` - Giochiamo 626 - Gaming for Health and Safety in Workplaces	N/A
Recruiting	`NCT05298800` - Combined Immunization of COVID-19 Inactivated Vaccine With QIV and PPV23	Phase 4
Completed	`NCT05188638` - Safety of Ascending Single and Multiple Doses of Nebulised SoftOx Inhalation Solution in Healthy Subjects	Phase 1
Completed	`NCT05145621` - Oral Bio-equivalence Study	Phase 1
Recruiting	`NCT05580159` - New Generation mRNA Booster Vaccine Against Emerging VOCs	Phase 3
Not yet recruiting	`NCT04596956` - Safety and Efficacy of Sodium Bicarbonate Ringer Injection	Phase 4
Completed	`NCT03033329` - Single Dose Escalation and Multiple Dose Escalation Trial of an Intravenous Formulation of MRX-4	Phase 1
Completed	`NCT01193335` - Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Preterm Compared to Term Infants.	Phase 4
Completed	`NCT03300466` - A Study to Evaluate the Performance and Safety of GP0045 for Correction of Moderate to Severe Nasolabial Folds	N/A
Active, not recruiting	`NCT05686161` - mRNA Booster Vaccine(SW-BIC-213) Compared With Pfizer andSinopharm Against Emerging VOCs	Phase 3
Recruiting	`NCT06046053` - MATRIX-002: Trial to Assess Acceptability and Safety of Two Placebo Vaginal Films	Early Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NeoMET Study in Neoadjuvant Treatment of Breast Cancer — NeoMET

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms