A randomized, controlled, open-label, phase III-trial on Adjuvant Dynamic marker - Adjusted Personalized Therapy comparing abemaciclib combined with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy in (clinical or genomic) intermediate to high risk, HR+/HER2- early breast cancer (ADAPTlate)

WSG Westdeutsche Studiengruppe GmbH83 sites in 3 countries1,700 target enrollmentDecember 8, 2023

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Not specified
Sponsor: WSG Westdeutsche Studiengruppe GmbH
Enrollment: 1700
Locations: 83
Primary Endpoint: iDFS since randomization
Status: Active, not recruiting
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To demonstrate superiority in invasive disease-free survival (iDFS) of abemaciclib + ET vs. standard ET.

Registry

euclinicaltrials.eu

Start Date

December 8, 2023

End Date

TBD

Last Updated

10 months ago

Sex

Female

Investigators

Sponsor

WSG Westdeutsche Studiengruppe GmbH

Responsible Party

Principal Investigator

Priv.-Doz. Dr. med. Oleg Gluz

Scientific

WSG Westdeutsche Studiengruppe GmbH

Eligibility Criteria

Inclusion Criteria

•Written informed consent prior to any study procedures (outcomes of standard-of-care procedures performed before signing of informed consent by the patient but within the allowed screening period can be used for patient screening).
•No clinical evidence of distant metastasis (confirmation recommended prior to randomization by either combination of or either one of the following examinations: CT thorax / abdomen, chest X-ray, liver ultrasound, bone scan, PET-CT).
•Patient has available tumor tissue from primary diagnostic biopsy.
•No contraindication for adjuvant ET.
•Eastern Cooperative Oncology Group (ECOG) performance status 0-
•Patient has adequate bone marrow and organ function as defined by the following laboratory values: absolute neutrophil count ≥ 1.5 × 109/L, platelets ≥ 100 × 109/L, hemoglobin ≥ 8.0 g/dL, total bilirubin ≤ 1.5 ULN, except for patients with Gilbert’s Syndrome who may only be included if the total bilirubin is ≤ 2.0 × ULN or direct bilirubin within normal ranges, aspartate transaminase (AST) ≤ 3 × ULN, alanine transaminase (ALT) ≤ 3 × ULN, serum creatinine ≤ 1.5 x ULN.
•Ability to swallow abemaciclib tablets or to administer other study medication, respectively.
•Ability to communicate with the investigator and comply with study procedures.
•Willing to receive therapy by clinical site, as required by the protocol.
•≥ 18 years of age.

Exclusion Criteria

•Patient with distant metastases of breast cancer beyond regional lymph nodes.
•Patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.
•Patient is currently receiving any of the following substances, which cannot be discontinued 7 days prior to day 1 of study treatment: concomitant medications and herbal supplements, that are strong inducers or inhibitors of CYP3A
•Participation in an investigational clinical trial AND being still under treatment with the investigational medicinal product, including the time until 30 days after last IMP treatment in the respective clinical trial.
•Not able to understand and to comply with study instructions and requirements.
•Pregnant or nursing (lactating) woman.
•Woman of child-bearing potential defined as woman physiologically capable of becoming pregnant, unless she is using highly effective methods of contraception during the study treatment and for 21 days after stopping the treatment: a. total abstinence (when this is in line with the preferred and usual lifestyle of the patient), b. female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks before taking study treatment, c. male partner sterilization (at least 6 months prior to study screening). For female patients on the study, the vasectomized male partner should be the sole partner for that patient, d. placement of a non-hormonal intrauterine device (IUD), e. Use of condom + spermicide.
•Use of oral (estrogen and progesterone), transdermal, injected, or implanted hormonal methods of contraception as well as hormone replacement therapy.
•Previously received CDK 4/6 inhibitor or patient with an indication for abemaciclib in the clinical routine per respective country: N 2-3 or N 1 and at least one of the following criteria: G3 or T3 and <14 months after primary diagnosis
•Patient with a known hypersensitivity to any of the excipients of abemaciclib or standard-of-care endocrine therapy.

Outcomes

Primary Outcomes

iDFS since randomization

Secondary Outcomes

iDFS since primary diagnosis
OS and dDFS since randomization
OS and dDFS since primary diagnosis
occurrence of CNS metastases since randomization
occurrence of CNS metastases since primary diagnosis
subgroup and multivariable survival analyses defined by key clinical, genomic, and endocrine response parameters
patient reported outcomes, quality of life (EORTC QLQ-C30, EORTC QLQ-BR23, EQ-5D-5L)
Efficacy of therapy according to distinct clinical and biological (measured by genomic signatures and other markers) prognostic subgroups