Breast CancerPhase 2NCT02826512
A Feasibility Study of Niraparib for Advanced, BRCA1-like, HER2-negative Breast Cancer Patients
A Phase 2 study testing Niraparib in people with Breast Cancer, run by The Netherlands Cancer Institute at 3 sites in Netherlands.
Trial summary
Patients with locally recurrent BRCA1-like, HER2-negative breast cancer that cannot be treated with curative intent by local treatment (surgery, radiotherapy +/- hyperthermia) or patients with metastatic BRCA1-like, HER2-negative breast cancer that have received a maximum of one prior line of treatment for incurable… 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 3 sitesNetherlands
- Study dates
- 15 May 2018to 1 Jul 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Histological proof of advanced, HER2 negative breast cancer;
- Fresh frozen primary tumor sample available or metastasis accessible for fresh frozen biopsy;
- The tumor must be BRCA1-like, as identified by Agendia's RNA-based BRCAness classifier;
- Only the following patients may be referred for BRCA1-like testing: all patients that had triple negative primary breast cancer; hormone-receptor positive, HER2-negative primary breast cancer patients with a histological grade III breast cancer; Breast cancer patients carrying a BRCA1 and/or BRCA2 germ line mutation.
- Pretreatment containing an anthracycline and/or taxane in the (neo-)adjuvant or metastatic setting received, or if not, then discussed with the patient whether it is justified to forego these treatments;
- Maximum of one prior line of chemotherapy for advanced disease.
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- Age ≥ 18 years;
- Able and willing to give written informed consent;
- WHO performance status of 0, 1 or 2;
- Life expectancy ≥ 3 months, allowing adequate follow up of toxicity evaluation and antitumor activity;
- Measurable or evaluable disease according to RECIST 1.1 criteria;
- Minimal acceptable safety laboratory values
- ANC of ≥ 1.5 x 109 /L
- Platelet count of ≥ 150 x 109 /L
- Hemoglobin ≥ 10 g/dL (6.21mmol/L)
- Hepatic function as defined by total serum bilirubin ≤ 1. 5 x ULN (except elevated bilirubin due to Gilbert's disease or a similar syndrome involving slow conjugation of bilirubin), ASAT and ALAT < 2.5 x ULN or <5 x ULN in case of liver metastasis
- Renal function as defined by serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min (by Cockcroft-Gault formula);
- Negative pregnancy test (urine/serum) for female patients with childbearing potential.
Who cannot join
- Any treatment with investigational drugs within 28 days prior to receiving the first dose of investigational treatment; or within 21 days for standard chemotherapy; or within 14 days for weekly scheduled chemotherapeutic regimens or endocrine therapy;
- Patients who have progressed on previous palliative treatment with PARP1-inhibitors, platinum compounds or high dose alkylating agents with autologous stem cell rescue, since preclinical and anecdotal clinical data in breast cancer indicate that these cancers have acquired resistance to PARP-inhibitors based on genetic reversion, epigenetic modifications, or as yet unknown mechanisms. Platinum-sensitive or PARP1-inhibitor-sensitive patients who stopped for reasons other than progression are eligible;
- Patients who received high-dose alkylating agents with autologous stem cell rescue in the (neo)adjuvant setting, unless these treatments had been received longer than 3 years ago;
- Pretreatment not containing an anthracycline and/or taxane, either in the (neo-) adjuvant or metastatic setting unless these treatments are not indicated;
- Women who have a positive pregnancy test (urine/serum) and/or who are breast feeding;
- Unreliable contraceptive methods. Women and men enrolled in this trial must agree to use a reliable contraceptive method throughout the study (adequate contraceptive methods are: oral, injected or implanted hormonal methods, intra-uterine devices or systems, condom or other barrier contraceptive measures, sterilization and true abstinence);
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- Radiotherapy within the last four weeks prior to receiving the first dose of investigational treatment; except 1x8 Gray for pain palliation then a seven days interval should be maintained;
- Patients must not have any known history of myelodysplastic syndrome (MDS) or other cytogenetic abnormality associated with MDS
- Patients must not have known persistent (> 4 weeks) ≥ Grade 2 toxicity from prior cancer therapy (except for alopecia gr 2).
- Patients must not have known ≥ Grade 3 hematological toxicity with the last chemotherapy regimen
- Uncontrolled infectious disease or known Human Immunodeficiency Virus HIV-1 or HIV-2 type patients;
- Patients with an active hepatitis B or C;
- Recent myocardial infarction (< six months) or unstable angina;
- Symptomatic brain metastases or leptomeningeal metastases. If adequately treated with resection and/or irradiation and patients are at least four weeks completely free of symptoms of these metastases and without medication related to these metastases (steroids are allowed) patients could be eligible if all other in- and exclusion criteria are obeyed;
- Any medical condition not yet specified above that is considered to possibly, probably or definitely interfere with study procedures, including adequate follow-up and compliance and/or would jeopardize safe treatment.
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Antoni van Leeuwenhoek
Amsterdam, 1066 CX
Deventer ziekenhuis
Deventer
Erasmus Medical Center Cancer Institute
Rotterdam, 3015CE
About this study
Official title: A Feasibility Study of Niraparib for Advanced, BRCA1-like, HER2-negative Breast Cancer Patients: the ABC Study
Patients with locally recurrent BRCA1-like, HER2-negative breast cancer that cannot be treated with curative intent by local treatment (surgery, radiotherapy +/- hyperthermia) or patients with metastatic BRCA1-like, HER2-negative breast cancer that have received a maximum of one prior line of treatment for incurable disease will be treated with Niraparib until disease progression
- Conditions
- Breast Cancer
- Being tested
- Niraparib
- Keywords
- BRCA1-like, HER2 negative
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NiraparibDrug
niraparib 300 mg QD continuously
| Study group | Role | What they receive |
|---|---|---|
| Niraparib | Experimental | niraparib 300 mg QD continuously Receives: Drug: Niraparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: From date of randomization until date of first documented progression or date of death, whichever comes first, assessed up to 120 months
Secondary outcomes (3)
Objective response rate
Measured: Assessed up to 120 months
Duration of response
Time from date of response to progression of disease
Measured: Assessed up to 120 months
Toxicity; Incidence of toxicity, graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4.03
Adverse events will be graded according to NCI Common Toxicity Criteria version 4.03
Measured: up to 30 days after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study start15 May 2018
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Why it stopped: Not enough eligble patient can be found, too many screen failures
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Tesaro, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02826512
- Sponsor's protocol ID
- M14ABC
- Status last verified
- Jul 2022
- First submitted
- 5 Jul 2016
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: to be determined
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Niraparib for Advanced, BRCA1-like, HER2-negative Breast Cancer Patients: the ABC Study
- ClinicalTrials.gov ID
- NCT02826512
- Acronym / sponsor ID
- M14ABC
- Conditions
- Breast Cancer
- Keywords
- BRCA1-like, HER2 negative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough eligble patient can be found, too many screen failures
- Enrolment
- 9 participants (actual)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Collaborators
- Tesaro, Inc.
- Study start
- 15 May 2018 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 11 Jul 2016 (estimated)
- 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.
Patients with locally recurrent BRCA1-like, HER2-negative breast cancer that cannot be treated with curative intent by local treatment (surgery, radiotherapy +/- hyperthermia) or patients with metastatic BRCA1-like, HER2-negative breast cancer that have received a maximum of one prior line of treatment for incurable disease will be treated with Niraparib until disease progression
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Niraparib | Experimental | Drug: Niraparibniraparib 300 mg QD continuously |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Histological proof of advanced, HER2 negative breast cancer;
- Fresh frozen primary tumor sample available or metastasis accessible for fresh frozen biopsy;
- The tumor must be BRCA1-like, as identified by Agendia's RNA-based BRCAness classifier;
- Only the following patients may be referred for BRCA1-like testing: all patients that had triple negative primary breast cancer; hormone-receptor positive, HER2-negative primary breast cancer patients with a histological grade III breast cancer; Breast cancer patients carrying a BRCA1 and/or BRCA2 germ line mutation.
- Pretreatment containing an anthracycline and/or taxane in the (neo-)adjuvant or metastatic setting received, or if not, then discussed with the patient whether it is justified to forego these treatments;
Key exclusion criteria (15 listed)
- Any treatment with investigational drugs within 28 days prior to receiving the first dose of investigational treatment; or within 21 days for standard chemotherapy; or within 14 days for weekly scheduled chemotherapeutic regimens or endocrine therapy;
- Patients who have progressed on previous palliative treatment with PARP1-inhibitors, platinum compounds or high dose alkylating agents with autologous stem cell rescue, since preclinical and anecdotal clinical data in breast cancer indicate that these cancers have acquired resistance to PARP-inhibitors based on genetic reversion, epigenetic modifications, or as yet unknown mechanisms. Platinum-sensitive or PARP1-inhibitor-sensitive patients who stopped for reasons other than progression are eligible;
- Patients who received high-dose alkylating agents with autologous stem cell rescue in the (neo)adjuvant setting, unless these treatments had been received longer than 3 years ago;
- Pretreatment not containing an anthracycline and/or taxane, either in the (neo-) adjuvant or metastatic setting unless these treatments are not indicated;
- Women who have a positive pregnancy test (urine/serum) and/or who are breast feeding;
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 |
|---|---|---|
| Niraparibniraparib 300 mg QD continuously | Drug | Niraparib |
Primary outcome
Progression free survival
Time frame: From date of randomization until date of first documented progression or date of death, whichever comes first, assessed up to 120 months
3 secondary outcomes
Objective response rate
Time frame: Assessed up to 120 months
Duration of response
Time frame: Assessed up to 120 months
Toxicity; Incidence of toxicity, graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4.03
Time frame: up to 30 days after end of treatment
Results and safety
The study was stopped early (reason given: Not enough eligble patient can be found, too many screen failures). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
- Individual participant dataSharing planned: Undecided. to be determined
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 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 Niraparib in people with Breast Cancer, run by The Netherlands Cancer Institute at 3 sites in Netherlands.
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 18 inclusion and 15 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: stopped early, as of the sponsor's last update on 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. 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?
The study was stopped early (reason given: Not enough eligble patient can be found, too many screen failures). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: From date of randomization until date of first documented progression or date of death, whichever comes first, assessed up to 120 months). 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 18 Jul 2022.