Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
A phase III multi-center, randomized, open-label trial to evaluate efficacy and safety of
ribociclib with endocrine therapy as adjuvant treatment in patients with HR+/HER2- Early
Breast Cancer
Phase
Phase 3
Funding Agency/Sponsor
Industrial
Disease
Breast Cancer
Enrollment Eligibility
Inclusion Criteria:
- Patient is ≥ 18 years-old at the time of PICF signature
- Patient is female with known menopausal status at the time of randomization or
initiation of adjuvant ET (whichever occurs earlier), or male.
- Patient with histologically confirmed unilateral primary invasive adenocarcinoma of
the breast with a date of initial cytologic or histologic diagnosis within 18 months
prior to randomization.
- Patient has breast cancer that is positive for ER and/or PgR
- Patient has HER2-negative breast cancer
- Patient has available archival tumor tissue from the surgical specimen
- Patient after surgical resection where tumor was removed completely, with the final
surgical specimen microscopic margins free from tumor, and belongs to one of the
following categories: anatomic stage group II or III
- If indicated, patient has completed adjuvant and/or neoadjuvant chemotherapy according
to the institutional guidelines
- If indicated, patient has completed adjuvant radiotherapy according to the
institutional guidelines
- Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Patient has no contraindication for the adjuvant ET in the trial and is planned to be
treated with ET for 5 years
Exclusion Criteria:
- Patient has received any CDK4/6 inhibitor
- Patient has received prior treatment with tamoxifen, raloxifene or AIs for reduction
in risk ("chemoprevention") of breast cancer and/or treatment for osteoporosis within
the last 2 years prior to randomization. Patient is concurrently using hormone
replacement therapy.
- Patient has received prior treatment with anthracyclines at cumulative doses of 450
mg/m² or more for doxorubicin, or 900 mg/m² or more for epirubicin.
- Patient with a known hypersensitivity to any of the excipients of ribociclib and/or ET
- Patient with distant metastases of breast cancer beyond regional lymph nodes (stage IV
according to AJCC 8th edition) and/or evidence of recurrence after curative surgery.
- Patient is concurrently using other anti-neoplastic therapy with the exception of
adjuvant ET
- Patient has had major surgery, chemotherapy or radiotherapy within 14 days prior to
randomization
- Patient has not recovered from clinical and laboratory acute toxicities related to
prior anti-cancer therapies
- Patient has a concurrent invasive malignancy or a prior invasive malignancy whose
treatment was completed within 2 years before randomization
- Patient has known HIV infection, Hepatitis B or C infection
- Clinically significant, uncontrolled heart disease and/or cardiac repolarization
abnormality
- Patient is currently receiving any of the following substances within 7 days before
randomization - Concomitant medications, herbal supplements, and/or fruits that are
known as strong inhibitors or inducers of CYP3A4/5 or Medications that have a narrow
therapeutic window and are predominantly metabolized through CYP3A4/5
- is currently receiving or has received systemic corticosteroids ≤ 2 weeks prior to
starting trial treatment
- Patient has impairment of GI function or GI disease that may significantly alter the
absorption of the oral trial treatments
- Patient has any other concurrent severe and/or uncontrolled medical condition that
would, in the Investigator's judgment, cause unacceptable safety risks, contraindicate
patient participation in the clinical trial or compromise compliance with the protocol
- Participation in other studies involving investigational drug(s) within 30 days prior
to randomization or within 5 half-lives of the investigational drug(s) (whichever is
longer), or participation in any other type of medical research judged not to be
scientifically or medically compatible with this trial.
- Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or
breast-feed during the trial