Recruiting

Observational Study

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT04579484

Conditions

Metastatic Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

This is a single-center prospective study involving analysis of circulating tumor DNA (ctDNA) and the gut microbiome in patients with metastatic breast cancer on standard of care endocrine therapy with an aromatase inhibitor in combination with an inhibitor of the cyclin-dependent kinases 4 and 6 (CDK 4/6). Up to 20 patients with Estrogen Receptor positive (ER+), Human Epidermal Growth Factor Receptor 2 negative (HER2-) metastatic breast cancer and Eastern Cooperative Oncology Group (ECOG) performance status 0-1 will be enrolled. This study involves the collection and analysis of patient samples and does not involve therapeutic intervention.

Conditions

Metastatic Breast Cancer

Study ID

NCT04579484

Start date

Feb 4, 2019

Status verified date

May, 2022

Completion date

Dec 31, 2022

Anticipated

Primary completion date

Dec 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Sign written and voluntary informed consent
  • Histological confirmation of advanced ER positive and HER2 negative breast cancer.
  • Adult patients at least 18 years of age
  • ECOG performance status equal to 0 or 1
  • Able to provide written informed consent
  • Must be willing to provide blood for ctDNA analysis on study enrollment and at specified study time points
  • Must be willing and able to perform stool sample collection
  • Patients must be suitable, as per their treating physician, for initiation of first line endocrine therapy with an aromatase inhibitor and a CDK 4/6 inhibitor for metastatic disease

Exclusion Criteria:

  • Prior treatment with CDK 4/6 inhibitors in the neoadjuvant or adjuvant setting
  • Use of targeted therapies other than endocrine therapies alone in the neoadjuvant or adjuvant setting
  • Relapse on prior endocrine therapy or within 6 months of discontinuation of prior adjuvant endocrine therapy
  • History of inflammatory bowel disease, chronic diarrhea or malabsorption syndromes and significant prior bowel resection as judged by the study investigator
  • Use of immunosuppressants including steroids within the previous 4 weeks of planned Cycle 1 Day 1 treatment

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Time to treatment failure [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Rossanna C. Pezo, MD/PhD

416-480-4757rossanna.pezo@sunnybrook.ca

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Rossanna C. Pezo, MD/PhD

416-480-4757rossanna.pezo@sunnybrook.ca

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

May 5, 2022

Last verified

May, 2022

Keywords

  • CDK4/6 inhibitors
  • endocrine resistance
  • gut microbiome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2022-05-05.