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New treatment option for Breast Cancer
Official title Ribociclib in Hormone Receptor-positive, HER2-negative Early Breast Cancer With Residual Disease After Neoadjuvant Chemotherapy
ClinicalTrials.gov ID: NCT07400523
What this study is testing
What is Ribociclib plus aromatase inhibitor?
Ribociclib plus aromatase inhibitor is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a multi-center, open-lable, prospective, randomized phase III clinical trial to investigate the efficacy and safety of adjuvant ribociclib combined with aromatase inhibitor in hormone receptor-positive, HER2-negative early breast cancer with residual disease after neoadjuvant chemotherapy
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Willingness for study participation with written informed consent
- Female with age at least 18 years
- Histologically confirmed unilateral or bilateral primary invasive breast cancer
- Residual invasive disease post-neoadjuvant either in the breast or as residual nodal invasion
- Histologically confirmed hormone receptor-positive (≥1% ER and/or PR positive stained cells) and HER2-negative (IHC 2+ with FISH-negative or IHC...
You likely can't join if
- c/pN+
- Known severe hypersensitivity reactions to compounds similar to ribociclib or to aromatase inhibitor
- Inadequate organ function immediate prior to randomization including: Hemoglobin \ 1.5 x upper limit of normal (ULN); alkaline phosphatase \> 2.5 x...
- Evidence for infection including wound infections, Human Immunodeficiency Virus (HIV) or any type of Hepatitis
- The cumulative dose of doxorubicin is more than 450mg/m² or epirubicin is more than 900mg/m²
- Uncontrolled electrolyte disorders (eg, hypocalcemia, hypokalemia, hypomagnesemia)
See the full eligibility criteria
- Willingness for study participation with written informed consent
- Female with age at least 18 years
- Histologically confirmed unilateral or bilateral primary invasive breast cancer
- Residual invasive disease post-neoadjuvant either in the breast or as residual nodal invasion
- Histologically confirmed hormone receptor-positive (≥1% ER and/or PR positive stained cells) and HER2-negative (IHC 2+ with FISH-negative or IHC 0-1+) assessed preferably on core biopsy of the breast or tissue from...
- Histologically confirmed Ki67 expression assessed preferably on core biopsy or post-neoadjuvant residual invasive disease of the breast, or if not possible, of residual nodal invasion. In case of bilateral breast...
- QTc interval \< 450 msec with mean resting heart rate 50-99 beats/min (determined by ECG)
- Patients must have received neoadjuvant chemotherapy of at least 18 weeks. This period must include 6 weeks of a taxane-containing neoadjuvant therapy (Exception: For patients with progressive disease that occurred...
- Adequate surgical treatment including resection of all clinically evident disease and ipsilateral axillary lymph node dissection. Histologically complete resection (R0) of the invasive and ductal in situ tumor is...
- Less than 16 weeks interval since the date of final surgery or less than 10 weeks from completing radiotherapy (whichever occurs last) at date of randomization
- Completion of adjuvant radiotherapy according to standard guidelines (e.g. NCCN) is strongly recommended. If radiotherapy is not performed the reason for this needs to be documented in the eCRF
- No clinical evidence for locoregional or distant relapse during or after preoperative chemotherapy. Local progression during chemotherapy is not an exclusion criterion
- c/pT3N0; c/pT2N0 with MammaPrint high-risk, G3, G2+Ki67 ≥20%, or lymphovascular invasion
- Eastern Cooperative Oncology Group performance status 0 or 1
- Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCI CTCAE version 4.0 Grade ≤1 (except alopecia or other toxicities not considered a safety risk for the patient at...
- Estimated life expectancy of at least 5 years irrespective of the diagnosis of breast cancer
- The patient must be accessible for scheduled visits, treatment and follow-up. Patients registered on this trial must be treated at the participating center which could be the Principal or a Co- investigator's site
- c/pN+
- Known severe hypersensitivity reactions to compounds similar to ribociclib or to aromatase inhibitor
- Inadequate organ function immediate prior to randomization including: Hemoglobin \ 1.5 x upper limit of normal (ULN); alkaline phosphatase \> 2.5 x ULN, total serum bilirubin \> 1.25 x ULN; serum creatinine \>1.25 x ULN...
- Evidence for infection including wound infections, Human Immunodeficiency Virus (HIV) or any type of Hepatitis
- The cumulative dose of doxorubicin is more than 450mg/m² or epirubicin is more than 900mg/m²
- Uncontrolled electrolyte disorders (eg, hypocalcemia, hypokalemia, hypomagnesemia)
- Any of the following within 6 months of randomization: myocardial infarction, severe/unstable angina, ongoing cardiac dysrhythmias of NCI CTCAE version 4.0 Grade ≥2, atrial fibrillation of any grade, coronary/peripheral...
- Active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or any upper gastrointestinal surgery including gastric resection
- Prior malignancy (including invasive or ductal in-situ breast cancer) within 5 years prior to randomization, except curatively treated basal cell carcinoma of the skin and carcinoma in situ of the cervix
- Current severe acute or uncontrolled chronic systemic disease (e.g. diabetes mellitus) or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational...
- Recent (within the past year) or active suicidal behavior
- Pregnancy or lactation period. Women of childbearing potential must implement adequate non-hormonal contraceptive measures (barrier methods, intrauterine contraceptive devices, sterilization) during study treatment and...
- Major surgery within 2 weeks prior to randomization
- 10 weeks or more have passed since completion of radiotherapy at day of randomization and 16 weeks interval since the date of final surgery have passed
- Prior treatment with any CDK4/6 inhibitor
- Patients treated within the last 7 days prior to randomization and/or concurrent use of drugs known to be strong CYP3A4 inhibitors or inducers
- Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to randomization
The study team makes the final eligibility decision.
Where it's taking place
- Zhanjiang, Guangdong, China
- Guangzhou, China
- Shantou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhanjiang, Guangdong, China; Guangzhou, China; Shantou, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.