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Completed

NCT Number: NCT04143282

Evaluation of the Effect of Metformin on Metastatic Breast Cancer as Adjuvant Treatment

This study aims to determine the effect of metformin along with standard cancer treatment, and its effect on the prognosis of the metastatic breast in non-diabetic patients.

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Beni-Seuf University Hospital

Banī Suwayf, Egypt

About this study

the role of metformin when combined with traditional metastatic breast cancer treatment in non-diabetic patients compared to diabetic patients who are not using metformin. In this randomized control study, there will be a demonstration either it is effective to suppress tumor burden or not through normal screening for tumor.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The non-diabetic patients will be included in the study if they meet the following criteria:
  • Confirmed metastatic breast cancer (IV stage) radiologically or by clinical evaluation receiving chemotherapy
  • Age between 18- 70 years.
  • Life expectancy at least 6 months

Exclusion criteria

  • The patients will be excluded from the study if they have the following criteria:
  • Bad prognosis disease: Criteria defined as the following
  • If patient >70 years
  • If patient has bad site metastasis (brain)
  • Hypersensitivity for metformin: if happened patient will be treated as following
  • Pheniramine Maleate 3 times daily for 7 days and Tablet Dexamethasone 1mg daily in 2 divided doses for 5 days [16].
  • Any condition associated with increased risk of metformin-associated lactic acidosis (e.g., congestive heart failure defined as New York Heart Association {NYHA} Class III or IV functional status; the history of acidosis of any type, severe infections, kidney or liver disease, respiratory disease, seizures .
  • Diabetic patients.

Treatment and study plan

Metformin plus chemotherapy

Drug

determine the effect of metformin along with standard chemotherapy

Chemotherapy

Drug

standard chemotherapy

Primary outcomes

  1. The radiologic response rate

    Time frame: 3 months

    The Response Evaluation Criteria in Solid Tumors (RECIST 1.1) was used to evaluate the response to chemotherapy alone in case of control arm and chemotherapy plus metformin in case of drug arm for breast cancer with distant metastasis

  2. Overall survival (OS)

    Time frame: 6 months

    the time period from the start of trial till death or end of follow-up

  3. Progression-free survival

    Time frame: 6 months

    from the time between start of the trial and recurrence or disease progression, or end of follow-up

Secondary outcomes

  1. Insulin Growth like Factor -1 (IGF-1) at base line and after 3 cycle.

    Time frame: 3 months

    measure blood Insulin Growth like Factor -1 (IGF-1) at the begining of trial then after 3 months at the end of 3 cycles (each cycle arround 28 days )

Sponsors and collaborators

Lead sponsor

Hager salah el din

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 29, 2019
Registry last updated
Dec 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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