Triple Negative Breast NeoplasmsPhase 2CAREGIVERNCT05067530
Cyclin dEpendent Kinase in tRiple nEGatIVe brEast canceR - a "Window of Opportunity" Study
A Phase 2 study testing Palbociclib, Paclitaxel and Carboplatin in people with Triple Negative Breast Neoplasms, run by Medical University of Gdansk at 6 sites in Poland.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triple Negative Breast Neoplasms
- What is being tested?
- Palbociclib, Paclitaxel and Carboplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 6 sitesPoland
- Study dates
- 1 Jan 2022to 6 Dec 2026
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- triple negative tumor defined as:
- hormone receptor-negative (<1% ER/PgR expression);
- HER2-negative (Immunohistochemistry (IHC) score ≤1 or IHC score =2 and negative for the amplification by in situ hybridization);
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- multicentric/multifocal disease is allowed, provided that all lesions have been biopsied and their phenotype has been confirmed pathologically as TNBC;
- no previous anticancer therapy for this malignancy;
- clinically or radiographically measurable disease (discrete lesion only, enhancement is not included) within the breast, that can be biopsied, defined as longest diameter >2 cm;
- multicentric or multifocal disease is allowed if at least 1 lesion is >2 cm;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- adequate bone marrow and organ function as defined by the following local laboratory values:
- hemoglobin ≥9 g/dL;
- absolute neutrophil count (ANC) ≥1500/μL;
- platelets ≥100,000/μL;
- total bilirubin ≤ institutional upper limit of normal (ULN), unless diagnosis of Gilbert syndrome;
- aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5x ULN;
- creatinine ≤ ULN OR creatinine clearance ≥50 mL/min per Cockcroft-Gault equation for patients with creatinine levels greater than ULN.
- blood glucose level <120 mg/dL after at least 6 hours of fasting;
- standard 12-lead electrocardiogram (ECG) without clinically significant abnormalities;
- ability to undergo contrast-enhanced MRI;
- ability to swallow and retain oral medication;
- all study participants of child-bearing potential must agree to use adequate contraceptive methods prior to study entry, during the study and for the following 3 weeks (females) or 14 weeks (males);
- prior chemotherapy, other targeted anticancer therapies, or prior radiation therapy (outside of treated breast) for other malignancy treated with radical intent is allowed, provided the treatment was completed ≥1 year before informed consent signature;
- prior bisphosphonate therapy is allowed;
- willing and able to undergo all the procedures required by the study protocol;
- provision of written informed consent form prior to receiving any study related procedure.
Who cannot join
- 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;
- major surgery or radiotherapy (apart from limited field radiotherapy for symptom control) within 14 days prior to randomization;
- concurrent invasive malignancy;
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- known HIV, active HBV or HCV infection;
- active autoimmune disease requiring ongoing immunosuppressive therapy;
- history of allotransplantation;
- concurrent treatment with systemic immunosuppressive agents, including steroids, within 3 weeks of enrolment;
- presence of implants or devices not compatible with MRI;
- pregnant or nursing female participants;
- receiving strong inhibitors or inducers of CYP3A4/5 or medications with narrow therapeutic window that are predominantly metabolized through CYP3A4/5;
- impairment of GI function that may significantly alter the absorption of the oral trial treatments;
- unwilling or unable to follow protocol requirements, including obligatory biopsies;
- any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drugs;
- any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator's judgment, contraindicate patient participation in the clinical trial or compromise compliance with the protocol.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Poland6 sites
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
Gdansk, Pomeranian Voivodeship, 80-952
Elżbieta Senkus-Konefka, MD, PhD
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie, Państwowy Instytut Badawczy, Oddział w Gliwicach
Gliwice, Silesian Voivodeship, 44-102
Michał Jarząb, MD, PhD, 32 278 88 86 ext. 0048, michal.jarzab@io.gliwice.pl
Michał Jarząb, MD, PhD
SP ZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarowskiego
Opole, Opole Voivodeship, 45-061
Barbara Stefania Radecka, MD, PhD, 77 441 60 01 ext. 0048, brad@onkologia.opole.pl
Barbara Stefania Radecka, MD, PhD
Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie, Oddział Onkologii Klinicznej i Immunoonkologii z Pododdziałem Dziennym
Poznan, Greater Poland Voivodeship, 61 885 05 57
Maria Małgorzata Litwiniuk, MD, PhD, 61 885 05 57 ext. 0048, maria.litwiniuk@wco.pl
Maria Małgorzata Litwiniuk, MD, PhD
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie
Warsaw, Masovian Voivodeship, 22 546 20 00
Agnieszka Jagiełło-Gruszfeld, MD, PhD, 22 546 20 00 ext. 0048, agnieszka.jagiello-gruszfeld@gmail.com
Agnieszka Jagiełło-Gruszfeld, MD, PhD
Dolnośląskie Centrum Onkologii we Wrocławiu, Oddział Onkologii Klinicznej/Chemioterapii, Poradnia Chemioterapii; Leczenie Nowotworów Piersi
Wroclaw, Lower Silesian Voivodeship, 53-413
Aleksandra Łacko, MD, PhD, 71 368 94 83 ext. 0048, aleksandra.lacko@umed.wroc.pl
Aleksandra Łacko, MD, PhD
About this study
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.
- Conditions
- Triple Negative Breast Neoplasms
- Being tested
- Palbociclib, Paclitaxel, Carboplatin
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalbociclibDrug
Also called Ibrance
CDK4/6 inhibitor
PaclitaxelDrug
Chemotherapy
CarboplatinDrug
Chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| CDK4/6 inhibitor alone: Palbociclib (IMP) | Experimental | Palbociclib alone (125 mg orally (PO) per day, days 1-14) Receives: Drug: Palbociclib |
| Chemotherapy alone: Paclitaxel | Active comparator | Paclitaxel alone (80 mg/m^2 intravenously (IV), day 1, 8, 15 and 22) Receives: Drug: Paclitaxel |
| CDK4/6 inhibitor + chemotherapy: Paclitaxel + Palbociclib | Experimental | Paclitaxel (80 mg/m^2 IV, day 1, 8, 15 and 22) + Palbociclib (125 mg PO per day, days 1-21) Receives: Drug: Palbociclib; Drug: Paclitaxel |
| Chemotherapy alone: Carboplatin | Active comparator | Carboplatin alone (area under the curve (AUC) 2 IV, day 1, 8, 15 and 22) Receives: Drug: Carboplatin |
| CDK4/6 inhibitor + chemotherapy: Carboplatin + Palbociclib | Experimental | Carboplatin (AUC 2 IV, day 1, 8, 15 and 22) + Palbociclib (125 mg PO per day, days 1-21) Receives: Drug: Palbociclib; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 27 (± 3 days)
Secondary outcomes (6)
SUVmax change
Difference in proportion of patients with SUVmax change above the predefined cut-off of 30% between chemotherapy + palbociclib vs chemotherapy alone arms.
Measured: Day 27 (± 3 days)
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.
Measured: Day 27 (± 3 days)
Metabolic tumor volume (MTV) difference
Difference in metabolic tumor volume (MTV) regression between chemotherapy + palbociclib vs chemotherapy alone arms.
Measured: Day 27 (± 3 days)
Tumor diameter change
Maximum tumor diameter change in largest continuous tumor mass based on MR imaging.
Measured: Day 27 (± 3 days)
Change in tumor characteristic
Change in tumor characteristic in Day 27 biopsy (presence of viable cancer cells).
Measured: Day 27 (± 3 days)
Treatment toxicity
Treatment toxicity (with special attention to myeloid toxicity to explore potential myeloprotective activity): number and severity of adverse events (AEs); toxicity will be described according to ICD-10 codes and graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).
Measured: Day 27 (± 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start1 Jan 2022 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion6 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- This 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)
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05067530
- Sponsor's protocol ID
- NBK 171/1/2021
- Other IDs
- 2021-001556-33
- Acronym
- CAREGIVER
- Status last verified
- Oct 2021
- First submitted
- 23 Sep 2021
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cyclin dEpendent Kinase in tRiple nEGatIVe brEast canceR - a "Window of Opportunity" Study
- ClinicalTrials.gov ID
- NCT05067530
- Acronym / sponsor ID
- CAREGIVER / NBK 171/1/2021
- Conditions
- Triple Negative Breast Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 6 Dec 2026 (estimated)
- First posted
- 5 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- This 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)
| Arm | Type | Receives |
|---|---|---|
| CDK4/6 inhibitor alone: Palbociclib (IMP) | Experimental | Drug: PalbociclibPalbociclib alone (125 mg orally (PO) per day, days 1-14) |
| Chemotherapy alone: Paclitaxel | Active comparator | Drug: PaclitaxelPaclitaxel alone (80 mg/m^2 intravenously (IV), day 1, 8, 15 and 22) |
| CDK4/6 inhibitor + chemotherapy: Paclitaxel + Palbociclib | Experimental | Drug: Palbociclib, Drug: PaclitaxelPaclitaxel (80 mg/m^2 IV, day 1, 8, 15 and 22) + Palbociclib (125 mg PO per day, days 1-21) |
| Chemotherapy alone: Carboplatin | Active comparator | Drug: CarboplatinCarboplatin alone (area under the curve (AUC) 2 IV, day 1, 8, 15 and 22) |
| CDK4/6 inhibitor + chemotherapy: Carboplatin + Palbociclib | Experimental | Drug: Palbociclib, Drug: CarboplatinCarboplatin (AUC 2 IV, day 1, 8, 15 and 22) + Palbociclib (125 mg PO per day, days 1-21) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- 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;
- triple negative tumor defined as:
- multicentric/multifocal disease is allowed, provided that all lesions have been biopsied and their phenotype has been confirmed pathologically as TNBC;
Key exclusion criteria (17 listed)
- 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;
- major surgery or radiotherapy (apart from limited field radiotherapy for symptom control) within 14 days prior to randomization;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PalbociclibAlso: IbranceCDK4/6 inhibitor | Drug | CDK4/6 inhibitor + chemotherapy: Carboplatin + Palbociclib, CDK4/6 inhibitor + chemotherapy: Paclitaxel + Palbociclib, CDK4/6 inhibitor alone: Palbociclib (IMP) |
| PaclitaxelChemotherapy | Drug | CDK4/6 inhibitor + chemotherapy: Paclitaxel + Palbociclib, Chemotherapy alone: Paclitaxel |
| CarboplatinChemotherapy | Drug | CDK4/6 inhibitor + chemotherapy: Carboplatin + Palbociclib, Chemotherapy alone: Carboplatin |
Primary outcome
Early metabolic response
Time frame: Day 27 (± 3 days)
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.
6 secondary outcomes
SUVmax change
Time frame: Day 27 (± 3 days)
Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST)
Time frame: Day 27 (± 3 days)
Metabolic tumor volume (MTV) difference
Time frame: Day 27 (± 3 days)
Tumor diameter change
Time frame: Day 27 (± 3 days)
Change in tumor characteristic
Time frame: Day 27 (± 3 days)
Treatment toxicity
Time frame: Day 27 (± 3 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Palbociclib, Paclitaxel and Carboplatin in people with Triple Negative Breast Neoplasms, run by Medical University of Gdansk at 6 sites in Poland.
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 27 inclusion and 17 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: opening soon, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Poland. 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 Elżbieta Senkus-Konefka, MD, PhD (58 584 4482 ext. 0048, elzbieta.senkus-konefka@gumed.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early metabolic response (time frame: Day 27 (± 3 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2021.