What is this trial studying for high anatomic stage breast cancer with low recurrence risk?

This trial is studying whether hormone therapy combined with ribociclib works as well as chemotherapy followed by hormone therapy plus ribociclib in patients with high anatomic stage breast cancer with low risk of recurrence. Researchers want to understand if chemotherapy can be avoided without reducing treatment effectiveness. The study is sponsored by the National Cancer Institute (NCI).

Who may be eligible for this breast cancer clinical trial?

Adults aged 18 years or older who are postmenopausal women or men with estrogen receptor-positive, HER2-negative breast cancer and low recurrence risk may be eligible. Participants must have had recent breast cancer surgery and meet specific health criteria including heart function and blood counts. Please review eligibility criteria for more details.

Is there any cost to participate in this breast cancer clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional costs.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID07391774

Phase III Study Comparing Hormone Therapy with Ribociclib to Chemotherapy Followed by Hormone Therapy with Ribociclib for Treating High Stage ER-positive, HER2-negative Breast Cancer with Low Recurrence Risk

Led by National Cancer Institute (NCI) · Updated on 2026-08-11

1978

Participants Needed

132

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are comparing two treatment approaches for patients with high anatomic stage estrogen receptor-positive, HER2-negative breast cancer who have a low risk of the cancer returning. The trial evaluates whether hormone therapy combined with the drug ribociclib works as well as chemotherapy followed by the same hormone therapy with ribociclib. Ribociclib targets enzymes needed for tumor cell growth, and hormone therapy lowers estrogen levels to help stop tumor growth. Chemotherapy works by killing or stopping the division and spread of cancer cells. Participants are first tested with the Oncotype DX assay to assess recurrence risk only those with scores between 0 and 25 continue. They are then randomly assigned to one of two groups one receives standard chemotherapy followed by hormone therapy plus ribociclib, and the other receives hormone therapy plus ribociclib without chemotherapy. Hormone therapy using letrozole, anastrozole, or exemestane is taken daily in 28-day cycles for at least five years, while ribociclib is taken daily for 21 days each cycle for up to three years. Patients undergo scans such as CT, bone scans, or PET-CT and may give blood samples during the study. Participants are followed closely with visits every 3 months during the first year, every 6 months for years 1 to 5, and annually for years 5 to 10. Researchers will assess invasive breast cancer-free survival up to 10 years and compare disease-free survival, recurrence rates, overall survival, and side effects between the two treatment groups. The study also aims to build a biorepository of tumor and blood samples for future research. This trial lasts until 2029, with ongoing monitoring to understand long-term outcomes and safety.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Patient is 18 years of age or older
Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 28 days prior to pre-registration
Patient is a postmenopausal woman or a man
Patient meets specific postoperative staging criteria according to AJCC 8th edition
Primary breast tumor is estrogen receptor-positive with more than 10% expression
Primary breast tumor is HER2-negative by current guidelines
Multicentric or multifocal breast cancer allowed if tumors meet eligibility
Surgical margins free of invasive tumor or ductal carcinoma in situ after lumpectomy or mastectomy with conditions
Patient underwent axillary staging with sentinel lymph node biopsy, targeted axillary dissection, or axillary lymph node dissection
No evidence of locoregional or distant metastatic disease
Patient is able to have Oncotype DX testing performed and has a recurrence score of 0-25
Final cancer surgery occurred less than 16 weeks prior to pre-registration
Patients with prior or concurrent malignancies not interfering with safety or efficacy assessment are eligible
Patients with synchronous DCIS or LCIS are eligible
Patient has no prior history of invasive ER-positive breast cancer
No prior endocrine therapy for chemoprevention within 5 years except short courses less than 6 weeks
Not concurrently using systemic hormone replacement therapy
Adequate blood counts and organ function within 28 days prior to pre-registration
HIV-infected patients on effective therapy with undetectable viral load are eligible
Patients with treated or controlled hepatitis B or C infection are eligible
Cardiac function assessed as New York Heart Association class 2 or better
ECG within 28 days prior to pre-registration with QTcF less than 450 msec and heart rate 50-90 bpm
Ability to understand and willingness to sign informed consent
No comorbidities posing safety risk for chemotherapy, endocrine therapy, or CDK4/6 inhibitor
No contraindication to adjuvant chemotherapy
No prior chemotherapy or CDK4/6 inhibitor for this malignancy
No known contraindications or hypersensitivity to ribociclib or endocrine therapy
Males must agree to use effective contraception and not father children during and for 12 weeks after treatment

You will not qualify if you...

Patients with T4 breast cancer
Patients with positive isolated tumor cells in axillary nodes without micro- or macrometastasis considered N0
Patients with prior history of invasive ER-positive breast cancer
Patients who received endocrine therapy for chemoprevention within 5 years except short courses less than 6 weeks
Concurrent systemic hormone replacement therapy
Blood counts or organ function outside required ranges
Untreated or uncontrolled HIV, hepatitis B or C infection
Cardiac function worse than New York Heart Association class 2
ECG QTcF 450 msec or higher or heart rate outside 50-90 bpm
Comorbidities posing safety risk for study treatments
Contraindications to adjuvant chemotherapy
Prior chemotherapy or CDK4/6 inhibitor treatment for the current cancer
Known hypersensitivity to ribociclib or endocrine therapy excipients
Males unwilling to use contraception or who plan to father children during study period

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Phase III Study Comparing Hormone Therapy with Ribociclib to Chemotherapy Followed by Hormone Therapy with Ribociclib for Treating High Stage ER-positive, HER2-negative Breast Cancer with Low Recurrence Risk

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria