Adjuvant Dynamic marker - Adjusted Personalized Therapy comparing endocrine therapy plus ribociclib versus chemotherapy in intermediate-risk, HR+/HER2- early breast cancer (ADAPTcycle)

WSG Westdeutsche Studiengruppe GmbH86 sites in 1 country1,684 target enrollmentJuly 2, 2019

DrugsKisqali 200 mg film-coated tablets LEE011

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Not specified
Sponsor: WSG Westdeutsche Studiengruppe GmbH
Enrollment: 1684
Locations: 86
Primary Endpoint: iDFS and dDFS
Status: Active, not recruiting
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To demonstrate

superiority in invasive disease-free survival (iDFS) of ribociclib + ET vs. standard-of-care chemotherapy,
survival rate >92 % in 5-years´ distant disease-free survival (dDFS) in the ribociclib + ET-group.

Detailed Description

The WSG ADAPT trial program is one of the first new generation trials addressing the issue of individualization of (neo)-adjuvant decision-making in early breast cancer (EBC) in a subtype-specific manner. The first WSG ADAPT umbrella trial (NCT01779206) aimed to establish early predictive molecular surrogate markers for response after a short 3-week induction treatment. The goals of the WSG ADAPT trial program - early response assessment and subtype-specific therapy tailoring to those patients who are most likely to benefit - have contributed to the very positive national and international feedback to the ADAPT concept as a whole. The aim of this ADAPTcycle phase-III-trial is to investigate whether the intermediate-risk patient group identified during the screening phase derives additional benefit from treatment with ribociclib in combination with ET compared to chemotherapy (followed by adjuvant ET).

Registry

euclinicaltrials.eu

Start Date

July 2, 2019

End Date

July 31, 2027

Last Updated

8 months ago

Study Type

Interventional

Sex

Female

Investigators

Sponsor

WSG Westdeutsche Studiengruppe GmbH

Responsible Party

Principal Investigator

Prof. Dr. med. Nadia Harbeck

Scientific

WSG Westdeutsche Studiengruppe GmbH

Eligibility Criteria

Inclusion Criteria

•Patients eligible for inclusion in this study have to meet all of the following criteria:
•A. Prior to REGISTRATION in the study:
•1\. Written informed consent prior to any screening procedures.
•≥ 18 years of age. 4a. EITHER: (Post)menopausal status at the time of initiation of (neo)adjuvant study medication
•patient underwent bilateral oophorectomy, or
•age ≥ 60, or
•age \< 60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression) and/or FSH and estradiol in the postmenopausal range per local normal range.
•4b. OR: Pre-menopausal patients:
•confirmed negative serum pregnancy test (β-hCG) before starting study treatment, or
•patient has had a hysterectomy.

Exclusion Criteria

•Patients eligible for inclusion in this study must not meet any of the following 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.
•Patient is currently receiving warfarin or other coumarin-derived anti-coagulant for treatment, prophylaxis, or otherwise.

Outcomes

Primary Outcomes

iDFS and dDFS

Secondary Outcomes

Pathological response rate (defined as ypT0/is/ypN0), as well as further definitions (ypT0/ypN0; ypT0/is/any ypN, near pCR (ypT1a/any ypN)),
Overall survival (OS) and dDFS,
quality of life (QoL)
treatment adherence (measured by drug intake),
local and central Ki-67 values in all tissue samples.
Rate of breast-conservation therapy
Clinical response rate (by palpation, ultrasound, and further methods),