A PHASE III, MULTICENTER, RANDOMIZED, OPEN-LABEL TRIAL TO EVALUATE EFFICACY AND SAFETY OF RIBOCICLIB WITH ENDOCRINE THERAPY AS AN ADJUVANT TREATMENT IN PATIENTS WITH HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE, EARLY BREAST CANCER (NEW ADJUVANT TRIAL WITH RIBOCICLIB [LEE011]: NATALEE)

Not Applicable

• Conditions: -Z853 Personal history of malignant neoplasm of breast; Personal history of malignant neoplasm of breast; Z853

• Registration Number: PER-016-19
• Lead Sponsor: OVARTIS BIOSCIENSES PERU S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-30
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Signed and dated Patient Informed Consent Form (PICF) obtained prior to any trial-specific screening procedure.
2. Patient is ≥ 18 years-old at the time of PICF signature.
3. Patient is female with known menopausal status at the time of PICF signature or initiation of adjuvant endocrine therapy (whichever occurs earlier), or male.
Postmenopausal status is defined as:
-Patient underwent bilateral oophorectomy, or
-Age ≥ 60 years, or
-Age < 60 years and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifen or ovarian suppression) and Follicle-stimulating hormone (FSH) and plasma estradiol are in the postmenopausal ranges per local normal ranges.
Note: for women with therapy-induced amenorrhea, serial measurements of FSH and/or estradiol per local clinical guidelines are required for determination of postmenopausal status.
All women who do not meet the criteria for postmenopausal status are considered premenopausal for the purpose of this trial.
4. 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 with a multicentric and/or multifocal tumor is eligible if all histopathologically examined lesions meet the pathologic criteria in inclusion criteria 5 and 6.
5. Patient has breast cancer that is positive for estrogen receptor and/or progesterone receptor according to the local laboratory as determined on the most recently analyzed tissue sample.
This exclusion criteria your can in the protocol

Exclusion Criteria

1. Patient has received any CDK4/6 inhibitor.
2. Patient has received prior treatment with tamoxifen, raloxifen or aromatase inhibitors for reduction in risk (chemoprevention”) of breast cancer and/or treatment for osteoporosis within the last 2 years prior to PICF signature.
3. 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.
4. Patient with a known hypersensitivity to any of the excipients of ribociclib and/or endocrine therapy (e.g. rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption, and soy allergy).
5. 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.
This others exclusion cirterian your can find in the protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified