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Discontinuation of CDK4/6 Inhibitors in Patients With Metastatic HR Positive, HER2 Negative Breast Cancer

ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

About this trial

This is a low-intervention, randomized, non-comparative, open-label, multicenter, prospective, phase II trial investigating discontinuation of CDK4/6 inhibitors in patients with metastatic HR positive, HER2 negative breast cancer with durable disease control.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female patient has given written informed consent

Patient is ≥ 18 years of age at time of signing the written informed consent

Patient has been diagnosed with histologically confirmed metastatic adenocarcinoma of the breast

Patient has documented histological or cytological confirmation of estrogen receptor positive (ER+) and HER2 negative (HER2-) disease

Disqualifiers

Patient has active (or history of) brain or leptomeningeal metastases

Patient is pre- or perimenopausal. Patient is pregnant or breast feeding or planning to become pregnant within five times the half-life of the IMPs after the end of treatment.

Patient has significant cardiovascular disease, such as cardiac disease (New York Heart Association Class II or greater), myocardial infarction or cerebrovascular accident within 6 months prior to initiation of study treatment, unstable arrhythmias, or unstable angina

Patient has other concomitant or previous malignancy, except adequately treated in-situ carcinoma of the uterine cervix, basal or squamous cell carcinoma of the skin, cancer in complete remission for > 5 years

Trial design

Design model

Parallel

Treatments tested in this trial

  • Continuation of CDK4/6 inhibitor Palbociclib

    Drug

    Continuation of CDK4/6 inhibitor Palbociclib

  • Discontinuation of CDK4/6 inhibitor Palbociclib

    Drug

    Discontinuation of CDK4/6 inhibitor Palbociclib

  • Continuation of CDK4/6 inhibitor -Palbociclib

    Drug

    Continuation of CDK4/6 inhibitor -Palbociclib

  • Discontinuation of CDK4/6 inhibitor -Palbociclib

    Drug

    Discontinuation of CDK4/6 inhibitor -Palbociclib

  • Continuation of CDK4/6 inhibitor Abemaciclib

    Drug

    Continuation of CDK4/6 inhibitor Abemaciclib

  • Discontinuation of CDK4/6 inhibitor Abemaciclib

    Drug

    Discontinuation of CDK4/6 inhibitor Abemaciclib

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Control arm CDK4/6 continuationActive comparator 3 interventions
Group B: Experimental arm CDK4/6 inhibitor discontinuationExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Progression-free survival rate 12 months after randomization (PFS@12_stopping)

Proportion of patients alive and without progression according to radiologic imaging assessment

Time frame
12 months

Secondary outcomes

1

Progression-free survival (PFS)

Time from randomization until progress

Time frame
54 months
2

Time to treatment failure (TTF)

Time from randomization to end of treatment because of patient's wish, investigator's decision, toxicity, or progression

Time frame
54 months
3

Progression-free survival (PFS2)

Time from re-treatment with CDK4/6 inhibitors to clinical disease progression or death from any cause

Time frame
54 months
4

Time to treatment failure (TTF2)

Time to end of treatment because of patient's wish, investigator's decision, toxicity, or clinical progression after re-treatment with CDK4/6 inhibitors

Time frame
54 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Lead sponsor

Source ClinicalTrials.gov
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