Health Trials

Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial

ConditionsAnatomic Stage II Breast Cancer AJCC v8Anatomic Stage IIIA Breast Cancer AJCC v8Anatomic Stage IIIC Breast Cancer AJCC v8Estrogen Receptor-Positive Breast CarcinomaHER2-Negative Breast Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cancer Institute (NCI)

About this trial

This phase III trial compares standard of care hormone therapy plus ribociclib to chemotherapy followed by hormone therapy plus ribociclib for the treatment of patients with high anatomic stage breast cancer with low risk of the cancer returning (low risk recurrence). Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hormone therapy, with letrozole, anastrozole or exemestane, lowers the amount of estrogen made by the body. This may help stop the growth of tumor cells that need estrogen to grow. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Hormone therapy plus ribociclib may work as well as chemotherapy followed by hormone therapy plus ribociclib for the treatment of high anatomic stage breast cancer with low recurrence risk.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

STEP 0: Patient must be ≥ 18 years of age

STEP 0: Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 28 days prior to Step 0 pre-registration

STEP 0: Patient must be a postmenopausal woman or a man

Prior bilateral oophorectomy

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Anastrozole

    Drug

    Given PO

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Bone Scan

    Procedure/Surgery

    Undergo bone scan

  • Chemotherapy

    Drug

    Receive standard of care chemotherapy

  • Computed Tomography

    Procedure/Surgery

    Undergo CT scan

  • Exemestane

    Drug

    Given PO

  • Letrozole

    Drug

    Given PO

  • Oncotype DX Breast Cancer Assay

    Procedure/Surgery

    Undergo risk recurrence testing

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo FDG PET scan

  • Ribociclib Succinate

    Drug

    Given PO

Treatment groups

1,978 Participants
are divided into 2 treatment groups
Group A: Arm A (chemotherapy, hormone therapy, ribociclib)Active comparator 10 interventions
Group B: Arm B (hormone therapy, ribociclib)Experimental treatment 9 interventions

Trial outcomes

Primary outcomes

1

Invasive breast cancer-free survival (iBCFS)

Invasive disease defined as the first occurrence of one of the following events: local invasive recurrence following mastectomy, local invasive recurrence in the ipsilateral breast following lumpectomy, regional recurrence, distant recurrence, or contralateral invasive breast cancer. The distribution of iBCFS will be estimated using the Kaplan-Meier method. The hazard ratio will be estimated using Cox proportional hazard model. The primary analysis will compare treatment groups defined by the randomized treatment assignment (intent-to-treat analysis). A secondary analysis will be performed comparing groups defined by treatment received (per protocol analysis).

Time frame
From randomization to invasive disease or death, up to 10 years

Secondary outcomes

1

Invasive disease free survival

Occurrence of invasive disease defined as the first occurrence of one of the following events: local invasive recurrence following mastectomy, local invasive recurrence in the ipsilateral breast following lumpectomy, regional recurrence, distant recurrence, contralateral invasive breast cancer, or second non-breast primary cancer (excluding squamous or basal cell carcinoma of the skin). Will be defined according to Standardized Definitions for Efficacy End Points (in Adjuvant Breast Cancer Trials) (STEEP) criteria and analyzed similarly as iBCFS.

Time frame
From randomization to the first occurrence of invasive disease or death, up to 10 years
2

Distant disease free survival

Will be defined according to STEEP criteria and analyzed similarly as iBCFS.

Time frame
Up to 10 years
3

Distant recurrence free survival

Will be defined according to STEEP criteria and analyzed similarly as iBCFS.

Time frame
Up to 10 years
4

Recurrence-free interval

Will be defined according to STEEP criteria and analyzed similarly as iBCFS.

Time frame
Up to 10 years

Other outcomes

1

Primary outcome treatment effect by sex

Estimates of treatment effect and the corresponding 95% confidence intervals (CIs) will be provided.

Time frame
Up to 10 years
2

Primary outcome treatment effect by race

Estimates of treatment effect and the corresponding 95% CIs will be provided.

Time frame
Up to 10 years
3

Primary outcome treatment effect by ethnicity

Estimates of treatment effect and the corresponding 95% CIs will be provided.

Time frame
Up to 10 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Cancer Institute (NCI)

Lead sponsor

Source ClinicalTrials.gov
Apply now