AzTrials
AzTrials

Breast CancerPhase 2NCT06207734

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

A Phase 2 study testing Continuation of CDK4/6 inhibitor Palbociclib, Discontinuation of CDK4/6 inhibitor Palbociclib and Continuation of CDK4/6 inhibitor -Palbociclib in people with Breast Cancer, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 13 sites in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Continuation of CDK4/6 inhibitor Palbociclib, Discontinuation of CDK4/6 inhibitor Palbociclib and Continuation of CDK4/6 inhibitor -Palbociclib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
13 sitesGermany
Study dates
17 Jan 2024to 10 Jul 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • Patient has no curative treatment option by surgery or radiotherapy
  • Patient was treated with CDK4/6 inhibitor plus endocrine therapy for at least 12 months with disease control (complete remission, partial remission or stable disease) as judged by the treating physician before planned study treatment initiation
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  • Patient has a preserved performance status (ECOG ≤ 2)
  • Patient has adequate bone marrow, renal and hepatic function:
  • Hemoglobin > 9.0 g/dL
  • Absolute neutrophil count judged as appropriate for study therapy by the investigator
  • Platelets ≥ 100 x 109/L
  • Calculated creatinine clearance judged as appropriate for study therapy by the investigator
  • AST (SGOT) / ALT (SGPT) and alkaline phosphatase ≤ 2.5x ULN
  • Serum albumin > 30 g/L
  • Patients considered postmenopausal according to one of the following definition:
  • Women <50 years of age who are amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and whose levels of luteinizing hormone and follicle-stimulating hormone are in the post-menopausal institutional range
  • Women ≥50 years of age who are amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago or had chemotherapy-induced menopause with last menses >1 year ago
  • Artificially induced postmenopausal women (by Gonadotropin-releasing hormone [GnRH] analogs)
  • WOCBP must have a negative serum pregnancy test within 7 days prior to start of trial

Who cannot join

  • 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
  • Patient has contraindication or shows hypersensitivity to the existing treatment with CDK4/6 inhibitor plus endocrine therapy
  • Patient shows evidence of any other disease, neurologic or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of any of the study medications, puts the patient at higher risk for treatment-related complications or may affect the interpretation of study results
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  • Patient participated in another clinical study with an investigational medicinal product during the last 28 days before treatment initiation or 7 half-lives of previously used trial medication, whichever is longer or participate in such a study at the same time as this trial.
  • Note: Participation in non-interventional clinical studies or registries is allowed.
  • Any co-existing medical condition that in the investigator's judgement will substantially increase the risk associated with the patient's participation in the study.
  • Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities.
  • Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts.

Trial locations and contacts

13 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Thomas Decker, Prof. contact

+49 751 366197 ext. 0

Thomas.Decker@onkonet.eu

Regina Eickhoff, Dr. contact

+49 69 / 5899 787 ext. 33

eickhoff.regina@ikf-khnw.de

13 sites in 1 country

Germany13 sites, 10 recruiting

  • Charité Berlin

    Berlin

    Recruiting

  • Hämatologische Onkologische Praxis im Medicum

    Bremen

    Recruiting

  • St. Johannes Hospital Dortmund

    Dortmund

    Active, not recruiting

  • Praxis und Tagesklinik

    Friedrichshafen

    Active, not recruiting

  • Hausärztliche und Onkologische Gemeinschaftspraxis

    Gerlingen

    Recruiting

  • Onkologische GP Gütersloh

    Gütersloh

    Active, not recruiting

  • Hämatologisch-Onkologische Praxis Altona

    Hamburg

    Recruiting

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz

    Recruiting

  • MVZ für Hämatologie und Onkologie der MVZ Mülheim GmbH

    Mülheim

    Recruiting

  • MVZ für Hämatologie und Onkologie

    Ravensburg, 88212

    Thomas Decker, Prof.

    Recruiting

  • Krankenhaus Barmherzige Brüder Regensburg

    Regensburg

    Recruiting

  • Onkologisch-Gastroenterologische Schwerpunktpraxis Innere Medizin GbR

    Singen, 78224

    Recruiting

  • Onkologiezentrum Soest-Iserlohn

    Soest, 59494

    Recruiting

Other trials in Germany

About this study

Official title: Discontinuation of CDK4/6 Inhibitors in Patients With Metastatic HR Positive, HER2 Negative Breast Cancer With Durable Disease Control: A Randomized Low-intervention Phase II Trial of the AIO Working Groups Breast Cancer and Quality of Life

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.

Read the detailed description

The primary objective is to evaluate long-term disease stabilization of CDK4/6 inhibitors discontinuation after a prolonged treatment period with continued endocrine therapy in breast cancer patients exhibiting at least stable disease after at least 12 months of combination treatment.

Conditions
Breast Cancer
Being tested
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
Keywords
Metastatic HR positive, HER2 negative breast cancer, CDK4/6 inhibitors, Endocrine therapy
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Continuation of CDK4/6 inhibitor PalbociclibDrug

    Also called Study treatment

    Continuation of CDK4/6 inhibitor Palbociclib

  • Discontinuation of CDK4/6 inhibitor PalbociclibDrug

    Also called Study treatment

    Discontinuation of CDK4/6 inhibitor Palbociclib

  • Continuation of CDK4/6 inhibitor -PalbociclibDrug

    Also called Study treatment

    Continuation of CDK4/6 inhibitor -Palbociclib

  • Discontinuation of CDK4/6 inhibitor -PalbociclibDrug

    Also called Study treatment

    Discontinuation of CDK4/6 inhibitor -Palbociclib

  • Continuation of CDK4/6 inhibitor AbemaciclibDrug

    Also called Study treatment

    Continuation of CDK4/6 inhibitor Abemaciclib

  • Discontinuation of CDK4/6 inhibitor AbemaciclibDrug

    Also called Study treatment

    Discontinuation of CDK4/6 inhibitor Abemaciclib

Study groups in NCT06207734
Study groupRoleWhat they receive
Control arm CDK4/6 continuationActive comparator* Continuation of CDK4/6 inhibitor treatment * Continuation of endocrine treatment
Receives: Drug: Continuation of CDK4/6 inhibitor Palbociclib; Drug: Continuation of CDK4/6 inhibitor -Palbociclib; Drug: Continuation of CDK4/6 inhibitor Abemaciclib
Experimental arm CDK4/6 inhibitor discontinuationExperimental* Discontinuation of CDK4/6 inhibitor treatment * Continuation of endocrine treatment
Receives: Drug: Discontinuation of CDK4/6 inhibitor Palbociclib; Drug: Discontinuation of CDK4/6 inhibitor -Palbociclib; Drug: Discontinuation of CDK4/6 inhibitor Abemaciclib

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 12 months

Secondary outcomes (8)

  1. Progression-free survival (PFS)

    Time from randomization until progress

    Measured: 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

    Measured: 54 months

  3. Progression-free survival (PFS2)

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

    Measured: 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

    Measured: 54 months

  5. Time to first use of chemotherapy

    Time to first use of chemotherapy after progression on combined endocrine/CDK4/6 inhibitor treatment

    Measured: 54 months

  6. Quality of life (QoL) EORTC QLQ-C30

    QoLassessed with the QoL questionnaire EORTC QLQ-C30

    Measured: 54 months

  7. Quality of life (QoL) EORTC QLQ-BR23

    QoLassessed with the QoL questionnaire EORTC QLQ-BR23

    Measured: 54 months

  8. Safety (rate of adverse events)

    Type, incidence and severity of adverse events (AEs) and serious adverse events (SAEs) graded according to NCI CTCAE v5.0

    Measured: 54 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2024
  2. Study start17 Jan 2024
  3. Primary completion10 Jan 2027 (estimated)
  4. Study completion10 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06207734
Sponsor's protocol ID
DISCUSS
Status last verified
Apr 2025
First submitted
3 Jan 2024
Last updated
1 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No IPD will be shared

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Continuation of CDK4/6 inhibitor Palbociclib, Discontinuation of CDK4/6 inhibitor Palbociclib and Continuation of CDK4/6 inhibitor -Palbociclib in people with Breast Cancer, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 13 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Thomas Decker, Prof. (+49 751 366197 ext. 0, Thomas.Decker@onkonet.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival rate 12 months after randomization (PFS@12_stopping) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06207734.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.

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