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OncoMatch/Clinical Trials/NCT06207734

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

Is NCT06207734 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments for breast cancer.

Phase 2RecruitingInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus NordwestNCT06207734Data as of Jun 2026Location: Germany

Treatment: Continuation of CDK4/6 inhibitor Palbociclib · Discontinuation of CDK4/6 inhibitor Palbociclib · Continuation of CDK4/6 inhibitor -Palbociclib · Discontinuation of CDK4/6 inhibitor -Palbociclib · Continuation of CDK4/6 inhibitor Abemaciclib · Discontinuation of CDK4/6 inhibitor AbemaciclibThis 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.

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Extracted eligibility criteria

Treatments studied

Other

Continuation of CDK4/6 inhibitor PalbociclibDiscontinuation of CDK4/6 inhibitor PalbociclibContinuation of CDK4/6 inhibitor -PalbociclibDiscontinuation of CDK4/6 inhibitor -PalbociclibContinuation of CDK4/6 inhibitor AbemaciclibDiscontinuation of CDK4/6 inhibitor Abemaciclib

Cancer type

Breast Carcinoma

Biomarker criteria

Required: ESR1 overexpression (positive)

estrogen receptor positive (ER+)

Required: HER2 (ERBB2) wild-type (negative)

HER2 negative (HER2-)

Disease stage

Metastatic disease required

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Demographics

Female only

Prior therapy

Must have received: CDK4/6 inhibitor — plus endocrine therapy for at least 12 months with disease control

treated with CDK4/6 inhibitor plus endocrine therapy for at least 12 months with disease control (complete remission, partial remission or stable disease)

Lab requirements

Blood counts

hemoglobin > 9.0 g/dl; absolute neutrophil count judged as appropriate for study therapy by the investigator; platelets ≥ 100 x 10^9/l

Kidney function

calculated creatinine clearance judged as appropriate for study therapy by the investigator

Liver function

ast (sgot) / alt (sgpt) and alkaline phosphatase ≤ 2.5x uln; serum albumin > 30 g/l

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT06207734 currently recruiting?

Yes, this trial is currently recruiting patients.

Is prior treatment required for enrollment?

Yes. Patients must have previously received CDK4/6 inhibitor.

Does this trial require ESR1?

Yes, ESR1 overexpression is a required biomarker for enrollment.

Does this trial require ERBB2?

Yes, ERBB2 wild-type is a required biomarker for enrollment.

Is this trial open to male patients?

No. This trial enrolls female patients only.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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