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Cyclin dEpendent Kinase in tRiple nEGatIVe brEast canceR - a "Window of Opportunity" Study

ConditionTriple Negative Breast Neoplasms
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of Gdansk

About this trial

CAREGIVER is a prospective, randomized, multicenter, open, five-arm study with unequal allocation ratios of 1:1:2:1:2 (palbociclib : paclitaxel : palbociclib + paclitaxel : carboplatin : carboplatin + paclitaxel). Study will be performed in untreated patients with triple-negative breast cancer (TNBC). Potential candidates without previously established diagnosis of TNBC will be included in a Pre-screening Phase, when a biopsy of breast tumor will be taken to confirm the diagnosis of cancer, select patients with TNBC and collect tissue for translational research.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

females or males >18 years old at the time of informed consent signature;

diagnosis of potentially resectable or de novo metastatic (stage II-IV) invasive carcinoma of the breast;

eligible for standard neoadjuvant or palliative paclitaxel and/or carboplatin-based chemotherapy as determined by Investigator;

hormone receptor-negative (<1% ER/PgR expression);

Disqualifiers

inflammatory breast cancer;

prior systemic treatment for this malignancy;

prior treatment with CDK4/6 inhibitor;

known hypersensitivity to study medications or any of their excipients;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Palbociclib

    Drug

    CDK4/6 inhibitor

  • Paclitaxel

    Drug

    Chemotherapy

  • Carboplatin

    Drug

    Chemotherapy

Treatment groups

126 Participants
are divided into 5 treatment groups
Group A: CDK4/6 inhibitor alone: Palbociclib (IMP)Experimental treatment 1 intervention
Group B: Chemotherapy alone: PaclitaxelActive comparator 1 intervention
Group C: CDK4/6 inhibitor + chemotherapy: Paclitaxel + PalbociclibExperimental treatment 2 interventions
Group D: Chemotherapy alone: CarboplatinActive comparator 1 intervention
Group E: CDK4/6 inhibitor + chemotherapy: Carboplatin + PalbociclibExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Early metabolic response

Difference in early (i.e., after three weeks of therapy, 1 cycle) metabolic response to treatment in chemotherapy-containing arms (chemotherapy ± palbociclib), as assessed by Blinded Central Review comparison of decrease in SUVmax between baseline and Day 27 (± 3 days) 18-fluoro-2-deoxy-d-glucose (18FDG) positron emission tomography - computed tomography (PET-CT). Primary analysis will include comparison between chemotherapy + palbociclib vs chemotherapy alone arms.

Time frame
Day 27 (± 3 days)

Secondary outcomes

1

SUVmax change

Difference in proportion of patients with SUVmax change above the predefined cut-off of 30% between chemotherapy + palbociclib vs chemotherapy alone arms.

Time frame
Day 27 (± 3 days)
2

Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST)

Difference in Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST)-based peak standardized uptake value corrected for lean body mass in a spherical 1 cm3 volume of interest (SULpeak) decrease in PET-CT between chemotherapy + palbociclib vs chemotherapy alone arms.

Time frame
Day 27 (± 3 days)
3

Metabolic tumor volume (MTV) difference

Difference in metabolic tumor volume (MTV) regression between chemotherapy + palbociclib vs chemotherapy alone arms.

Time frame
Day 27 (± 3 days)
4

Tumor diameter change

Maximum tumor diameter change in largest continuous tumor mass based on MR imaging.

Time frame
Day 27 (± 3 days)

Other outcomes

Sponsors and contacts

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

Medical University of Gdansk

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: