Neoadjuvant Toremifene With Melatonin or Metformin in Locally Advanced Breast Cancer

  • STATUS
    Recruiting
  • End date
    Aug 23, 2022
  • participants needed
    96
  • sponsor
    N.N. Petrov National Medical Research Center of Oncology
Updated on 23 January 2021
advanced breast cancer
locally advanced breast cancer
breast cancer staging

Summary

This study evaluates the addition melatonin and metformin to toremifene in the treatment of locally advanced breast cancer. Third of patients will receive toremifene, other third will receive combination of melatonin and toremifene and other patients will receive combination of metformin and toremifene.

Description

The management of locally advanced breast cancer is complicated issue. Neoadjuvant treatment is often needed to downstage locally advanced ER positive BC tumors prior to surgery. However, many patients do not achieved objective response on treatment. The ability of melatonin and metformin to decrease side effects of chemotherapy had been investigated, moreover, several studies confirm, that this drugs in combination with conventional anti - estrogen treatment may increase objective response. But, this data is still controversial. We hypothesizes that the combinations of melatonin and metformin with conventional anti - estrogen such as toremifene could be more effective than toremifene alone in terms of response rate.

Details
Condition Breast Cancer, Breast Cancer Diagnosis, breast carcinoma, cancer, breast
Treatment Metformin, Melatonin, Toremifene
Clinical Study IdentifierNCT02506790
SponsorN.N. Petrov National Medical Research Center of Oncology
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you female?
Do you have Breast Cancer?
Do you have any of these conditions: Breast Cancer or Breast Cancer Diagnosis or breast carcinoma or cancer, breast?
Age > 18\
Obtained Inform Concent
Morphologically confirmed breast cancer stage IIB, IIIA, IIIB, IIIC ER positive
Eastern Collaborative Oncology Group Performance Status Scale 0-2
Expected survival > 6 month
Adequate liver and bone marrow function

Exclusion Criteria

Systemic treatment for breast cancer
Stage IV disease
Evidence of liver and bone marrow clinically meaningful disfunction
Severe uncontrolled concomitant conditions and diseases
Pregnancy or lactation
Second malignancy
Diabetes mellitus requiring drug therapy
Any condition preventing study participation by investigators opinion
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note