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Breast CancerPhase 1/2CAPRICENCT05519670

A Phase 1b/2 Trial Evaluating Safety and Efficacy of CAPecitabine in Combination With Ni-rapaRIb in HER2-negative Advanced Breast canCEr

A Phase 1/2 study testing Niraparib Oral Product in people with Breast Cancer, run by Institut Paoli-Calmettes.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This study will be to combine oral capecitabine and oral niraparib such thz association may increase clinical benefits of PARP inhibitors in germline BRCA mutated HER2 negative advanced breast cancer patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Niraparib Oral Product
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
No sites listed yet
Study dates
Mar 2023to Dec 2027
Phase
Phase 1/2
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

  • Women or men aged 18 or more
  • Histologically-confirmed advanced breast cancer (metastatic or locally advanced)
  • Tumor without overexpression of HER2 (HER2 1+ in IHC, or IHC 2+ and FISH/ CISH negative) in samples from the primary and/or secondary tumor
  • Hormone receptor status known
  • Endocrine insensitive (hormone receptor negative or Endocrine (aromatase inhibitor)-resistant (a CDK4/6-based endocrine treatment must have been administered as a first-line of second-line treatment, unless primary endocrine-refractory disease as defined as relapse within the first 2 years of aromatase-based adjuvant endocrine therapy or progression under endocrine treatment administered for metastatic disease within 6 months of initiation))
  • Progressive disease patients who are eligible to a treatment with capecitabine: after fail-ure to taxanes and anthracycline-based chemotherapy (unless contraindicated) (neoadjuvant, adjuvant or metastatic setting)
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  • A representative tumor specimen must be available for molecular testing. An archival tu-mor sample may be submitted (<6 months); however, if one is not available, a newly obtained tumor biopsy specimen must be submitted instead
  • Measurable disease according to RECIST1.1
  • Symptomatic, untreated, or actively progressing central nervous system (CNS) metasta-ses are not eligible. Patients with a history of treated CNS lesions are eligible, provided all of the following criteria are met:
  • Measurable or non-measurable disease, per RECIST v. 1.1, must be present outside the CNS
  • No history of intracranial haemorrhage or spinal cord haemorrhage
  • Metastases are limited to the cerebellum or the supratentorial region (i.e., no metasta-ses to the midbrain, pons, medulla, or spinal cord).
  • There is no evidence of interim progression between completion of CNS-directed ther-apy and the screening brain scan.
  • The patient has not received stereotactic radiotherapy within 7 days prior to initiation of study treatment or whole-brain radiotherapy within 14 days prior to initiation of study treatment.
  • The patient has no ongoing requirement for corticosteroids as therapy for CNS disease. Anticonvulsant therapy at a stable dose is permitted.
  • Asymptomatic patients with CNS metastases newly detected at screening are eligible for the study after receiving radiotherapy or surgery, with no need to repeat the screening brain scan.
  • 10. Patients must have an estimated survival of at least 3 months 11. WHO performance status (ECOG) from 0 to 1 12. Adequate hematological and coagulation function: Hb ≥ 10.0 g/dL, ANC ≥ 1500/mm3 platelets ≥ 150 000/mm3, INR ≤ 1.5 13. Adequate hepatic function : total serum bilirubin ≤ 1x ULN, or total bilirubin ≤ 2.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert's Syndrome, ALAT and ASAT ≤ 1.5 x ULN 14. Adequate renal function: serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60mL/min 15. Adequate ionic balance: potassium, calcium (corrected for serum albumin), magnesium, sodium and phosphorus within normal limits for the institution 16. Participant must have normal blood pressure or adequately treated and controlled hyperten-sion17. A female participant is eligible if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
  • Is not a woman of childbearing potential (WOCBP) OR
  • Is a WOCBP and must agree to use a highly effective contraceptive method (described in 6.6.2) while on treatment and for at least 180 days after study drugs discontinuation.
  • 18. A WOCBP must have a negative pregnancy test (highly sensitive urine test or serum test as required by local regulations) within 72 hours before the first dose of study treatment.
  • 19. Male participants are eligible to participate if they agree to the following during the interven-tion period and for at least 90 days after the last dose of study treatment:
  • Refrain from donating sperm
  • Must agree to use a male condom (and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak) 20. Patient must be affiliated to a Social Security system 21. Patient information and written informed consent form signed 22. Must be able to swallow and retain orally administered study treatment. 23. For expansion cohort: inclusion will be done regarding availability of homologous recom-bination status

Who cannot join

  • Prior treatment with a PARP inhibitor and capecitabine for metastatic disease, (Patients treat-ed with these drugs in the adjuvant setting are allowed to participate if they experienced 2 years from end of treatment and metastatic relapse)
  • Patient has a Dihydropyrimidine dehydrogenase deficiency (DPD)
  • Patients must not have received anticancer chemotherapy, targeted therapy within 2 weeks prior of the study. Endocrine therapy must have been discontinued 7 or more days before Cycle 1 Day 1. Participant must not have had investigational therapy administered within 4 weeks or with-in a time interval less than at least 5 half-lives of the investigational agent, whichever is longer, prior to the first scheduled day of dosing in this study.
  • Palliative radiotherapy must have been completed 14 or more days before Cycle 1 Day 1. Biphosphonates and denosumab are allowed.
  • Major surgery within 3 weeks prior to registration. Patients must have recovered from earlier major surgery before registration.
  • Persistent toxicities (≥NCI-CTCAE grade 2) caused by previous cancer therapy, excluding alopecia and NCI-CTCAE grade 2 peripheral neuropathy.
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  • Immunocompromised patients (e.g. HIV) for part I and but patients with well controlled HIV could be included in part II (negative viral load)
  • Patients considered at poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection, symptomatic congestive heart fail-ure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses, or Posterior Reversible Encephalopathy Syn-drome (PRES).
  • Mean resting QT interval corrected for heart rate (QTc) ≥470 ms calculated from 3 consecutive electrocardiograms using Fridericia's Correction.
  • Active or prior documented inflammatory bowel disease (Crohn's disease, ulcerative colitis).
  • Patients unable to swallow orally administered medication, patients with gastrointestinal dis-orders likely to interfere with absorption of niraparib, and patients with long-term oral anticoagu-lant therapy.
  • Pregnant or breast-feeding women. Participant must agree to not breastfeed during the study and for 30 days after the last dose of study treatment
  • Known hypersensitivity to niraparib or capecitabine or any of the excipients of the products
  • Patient is currently receiving or has received sorivudine or brivudine within 4 weeks prior to starting capecitabine
  • Patient has received a transfusion (platelets or red blood cells) ≤ 4 weeks prior to initiating protocol therapy
  • Patient has received colony-stimulating factors (e.g. granulocyte colony-stimulating factor, granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) ≤ 4 weeks prior to initiating protocol therapy
  • Patient has had any known Grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted > 4 weeks
  • Patient has any known history of myelodysplastic syndrome (MDS) or acute myeloid leuke-mia (AML)
  • Patient has a diagnosis, detection, or treatment of another type of cancer ≤ 2 years prior to initiating study therapy with the following exceptions: basal or squamous cell carcinoma of the skin, cervical cancer in situ that has been definitively treated, adequately treated nonmelanoma skin cancer, ductal carcinoma in situ (DCIS) of the breast.
  • Patient has known active hepatitis B (e.g. hepatitis B surface antigen (HBsAg] reaction) or hepatitis C (e.g. hepatitis C virus [HCV] ribonucleic acid [qualitative] is detected)
  • Participants have received live vaccine within 30 days of planned start of study registration. 22. Participants have current active pneumonitis or any history of pneumonitis requiring steroids (any dose) or immunomodulatory treatment within 90 days of planned start of the study.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

CECILE VICIER, DR contact

+33 4 91 22 38 47

vicierc@ipc.unicancer.fr

About this study

This study will be to combine oral capecitabine and oral niraparib such thz association may increase clinical benefits of PARP inhibitors in germline BRCA mutated HER2 negative advanced breast cancer patients.

Read the detailed description

In spite of multimodal treatment, prognosis of HER2 negative metastatic breast cancers remains poor and innovative targeted therapeutic approaches are urgently warranted. While PARP inhibi-tors as single agent have demonstrated moderate improvement in progression-free survival and quality of life in pre-treated HER2 negative advanced breast cancer patients with germline BRCA mutation, they failed to improve overall survival in this setting. In addition, most of clinical trials testing combinations of chemotherapy and PARP inhibitors have been limited by overlapping hematological toxicities, or have used low dosage PARP inhibitors with short exposure time and with uncertain benefits. The therapeutic strategy selected in this study will be to combine oral capecitabine (2 weeks on, 1 week off, as recommended in monotherapy) and oral niraparib (con-tinuously for a cycle of 21 days). Such an association may increase clinical benefits of PARP inhibitors in germline BRCA mutated HER2 negative advanced breast cancer patients, while po-tentially expanding clinical interest of PARP inhibitors in patients without germline BRCA muta-tion (either with or without HRD).

Conditions
Breast Cancer
Being tested
Niraparib Oral Product
Medical subject headings
Breast Neoplasms

What participants receive

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

  • Niraparib Oral ProductDrug

    Niraparib + capecitabine treatment

Study groups in NCT05519670
Study groupRoleWhat they receive
Only ArmExperimentalniraparib + capecitabine treatment
Receives: Drug: Niraparib Oral Product

What is being measured

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

  1. Dose-Limiting Toxicities (DLT)

    incidence of Dose-Limiting Toxicities (DLT)

    Measured: 3 weeks

  2. efficacy with objective response rate (ORR)

    rate of patients experiencing an objective response

    Measured: 6 months

Secondary outcomes (2)

  1. adverse events

    incidence of adverse events

    Measured: 6 months

  2. Pharmacokinetics (PK)

    Plasma concentrations and basic PK parameters of niraparib and capecitabine when adminis-tered in combination

    Measured: 15 days

Timeline

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

  1. First posted29 Aug 2022
  2. Study startMar 2023 (estimated)
  3. Primary completionSep 2027 (estimated)
  4. Study completionDec 2027 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05519670
Sponsor's protocol ID
CAPRICE-IPC 2020-053
Acronym
CAPRICE
Status last verified
Aug 2022
First submitted
26 Aug 2022
Last updated
29 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Niraparib Oral Product in people with Breast Cancer, run by Institut Paoli-Calmettes.

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 23 inclusion and 21 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 29 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 CECILE VICIER, DR (+33 4 91 22 38 47, vicierc@ipc.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-Limiting Toxicities (DLT) (time frame: 3 weeks). The study lists 2 primary outcomes in all. 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 NCT05519670.

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 29 Aug 2022; AzTrials last refreshed its copy on 1 Nov 2026.

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