Active — Not RecruitingPhase 3

Adj. Marker-adjusted Personalized Therapy Comparing ET+Ribociclib vs Chemotherapy in Intermediate Risk, HR+/HER2- EBC

Germany1,684 participantsStarted 2019-07-02

Plain-language summary

The study investigates, whether the patient group with intermediate-risk early breast cancer benefits from treatment with ribociclib in combination with endocrine therapy compared to standard-of-care chemotherapy (followed by adjuvant endocrine therapy).

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. cT2-4
✓. c/pN positive
✓. G3 and / or Ki-67 ≥ 20% Note: Inclusion of a patient according to "clinical intermediate risk" is permitted only in case of missing baseline Oncotype DX® or Ki-67 decrease. In this case, investigators will follow a risk-based, step-wise assessment process.

Exclusion criteria

✕. Patient with distant metastases of breast cancer beyond regional lymph nodes.
✕. Patient has received prior (neo)-adjuvant treatment with chemotherapy, ET, or any CDK4/6 inhibitor for breast cancer.
✕. Patient has received tamoxifen, raloxifene, or aromatase inhibitors (AIs) for reduction in risk ("chemoprevention") of breast cancer and/or treatment for osteoporosis within last 2 years prior to screening.
✕. Patient has received prior neoadjuvant/adjuvant 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, ET, or standard-of-care chemotherapy.
✕. Patient with inflammatory breast cancer at screening.
✕. Patient is concurrently using other anti-cancer therapy.
✕. Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects.

What they're measuring

invasive disease-free survival (iDFS)

Timeframe: at end of study, on average 5 years after start of treatment

distant disease-free survival (dDFS)

Timeframe: at end of study, on average 5 years after start of treatment

Trial details

NCT IDNCT04055493

SponsorWest German Study Group

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07-31

View on ClinicalTrials.gov More Breast Cancer Female trials