RightFit
RecruitingPhase not listed

DiviTum®TKa: A Biomarker Assay for Efficacy in HR+ Breast Cancer Patients

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at whether DiviTum®TKa test results show patterns linked to how well breast cancer treatment works. It focuses on hormone receptor-positive (HR+), HER2-negative breast cancer treated with hormone therapy alone or with drugs called CDK4/6 inhibitors, which slow cancer cell growth.

This study is being done to determine if there is a pattern associated with response to endocrine therapy alone and in combination with CDK4/6 inhibitor used for hormone receptor positive HER2 negative breast cancer.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You may be before or after menopause, when monthly periods stop. Your cancer must be HR+, meaning hormones help it grow, and fit one of the groups below.
  • Group 1: Breast cancer has spread to other parts of the body. You plan to start your first treatment with hormone therapy plus palbociclib, ribociclib, or abemaciclib.
  • Group 2: Breast cancer has spread. You plan to start your second or later treatment with palbociclib, ribociclib, or abemaciclib, with or without hormone therapy.
  • Group 3: Breast cancer has spread. You are already getting your first treatment with hormone therapy plus palbociclib, ribociclib, or abemaciclib.
  • Group 4: Breast cancer has spread. You plan to start, or already get, hormone therapy alone as your first or second treatment.
  • Group 5: You have stage 2 or 3 breast cancer. You plan to start, or already get, ribociclib or abemaciclib plus hormone therapy as your first treatment after the main cancer treatment.
  • The treatments listed for these groups must be FDA-approved.
  • You may join even if you are in another clinical trial, as long as you meet this study's requirements.

Who can't join

  • Your treatment includes an experimental drug or therapy.
  • You have an early breast cancer diagnosis. The listing also includes stage 2 or 3 cancer in Group 5; ask the study team to clarify.
  • You are male and have breast cancer.
  • You are being treated for another active cancer when you sign up. Exceptions are nonmelanoma skin cancer and carcinoma in situ, which means abnormal cells have not spread beyond where they started.
  • You cannot give written consent to join the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Pre- or post-menopausal HR+ metastatic breast cancer patients who are: * Group 1: scheduled to initiate 1st line combination therapy with an FDA-approved CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) and an FDA-approved endocrine therapy for pre- or post-menopausal HR+ metastatic breast cancer (mBC). * Group 2: scheduled to initiate second or later lines of therapy with an FDA-approved CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) with or without an FDA-approved endocrine therapy for pre- or post-menopausal HR+ mBC. * Group 3: currently receiving 1st line therapy with an FDA-approved CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) and an FDA-approved endocrine therapy for pre- or post-menopausal HR+ mBC. * Group 4: scheduled to initiate, or are currently receiving, 1st or 2nd line therapy of an FDA approved endocrine therapy (single agent) for pre- or post-menopausal HR+ mBC. * Group 5: scheduled to initiate or are currently receiving 1st line therapy of an FDA-approved CDK4/6 inhibitor (ribociclib or abemaciclib) with an FDA approved endocrine therapy for stage 2 or stage 3 adjuvant HR+ BC NOTE: Patients that meet eligibility criteria for any of the above groups that are already enrolled in an ongoing clinical trial are eligible for co-enrollment to this observational study. Exclusion Criteria: * Treatment including investigational agent or therapies * Early breast cancer diagnosis * Male breast cancer * Currently receiving treatment for other active malignancy at time of registration * EXCEPTIONS: Nonmelanoma skin cancer or carcinoma-in-situ (e.g. of cervix, prostate) * Inability to give written informed consent

Study sites (1)

FL