Trials / Active Not Recruiting
Active Not RecruitingNCT03281902
Genetic Analysis in Blood and Tumor Samples From Patients With Advanced or Metastatic Estrogen Receptor Positive and HER2 Negative Breast Cancer Receiving Palbociclib and Endocrine Therapy
Prospective Study to Evaluate the Role of Tumor Sequencing in Women Receiving Palbociclib for Advanced Hormone Receptor (HR)-Positive, Breast Cancer (PROMISE)
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 68 (actual)
- Sponsor
- Mayo Clinic · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This research trial studies genetic profiles in blood and tumor samples from patients with estrogen receptor positive and HER2 negative breast cancer that has spread to other places in the body who are receiving palbociclib and endocrine therapy. Examining the genetic changes associated with the cancer and comparing the genetic material from the cancer tissue with the genetic material found in the blood may help doctors to develop customized treatment for breast cancer.
Conditions
- Advanced Breast Carcinoma
- Locally Advanced Breast Carcinoma
- Metastatic Breast Carcinoma
- Recurrent Breast Carcinoma
- Stage III Breast Cancer AJCC v7
- Stage IIIA Breast Cancer AJCC v7
- Stage IIIB Breast Cancer AJCC v7
- Stage IIIC Breast Cancer AJCC v7
- Stage IV Breast Cancer AJCC v6 and v7
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Biopsy | Undergo tumor biopsy |
| PROCEDURE | Biospecimen Collection | Undergo collection of blood, urine, stool, and saliva |
| OTHER | Laboratory Biomarker Analysis | Correlative studies |
Timeline
- Start date
- 2017-11-13
- Primary completion
- 2026-03-04
- Completion
- 2026-03-04
- First posted
- 2017-09-13
- Last updated
- 2025-03-06
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT03281902. Inclusion in this directory is not an endorsement.