Neoplasms, BreastPhase 1NCT03329937

Study Evaluating the Antitumor Activity and Safety of Niraparib as Neoadjuvant Treatment in Participants With Breast Cancer

A Phase 1 study testing Niraparib in people with Neoplasms, Breast, run by Tesaro, Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Neoplasms, Breast
What is being tested?: Niraparib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: No sites listed yet
Study dates: 12 Apr 2018to 31 Mar 2020
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Participants age >= 18 years old.
Participants with a deleterious or suspected deleterious breast cancer susceptibility gene 1 (BRCA1) or BRCA2 mutation (germline or somatic) may be enrolled into the study based on either local or central laboratory testing of BRCA status.
Histologically-confirmed HER2-negative localized breast cancer by core biopsy.
Primary operable, non-metastatic invasive carcinoma of the breast, confirmed histologically by core biopsy. Fine-needle aspiration is not sufficient. Incisional biopsy is not allowed. In participants with multifocal and/or multicentric, the largest lesion should be measured. Both unilateral and bilateral breast cancer are allowed.
Primary tumor size >=1cm.
Measurable disease by breast ultrasound and MRI.

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Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Adequate organ function defined as:
Absolute neutrophil count (ANC) >=1500 per microliters (/μL).
Platelets >=100,000/μL.
Hemoglobin >=9 grams per deciliter (g/dL).
Serum creatinine <=1.5*upper limit of normal (ULN) or calculated creatinine clearance >=50 milliliters per minute (mL/min) using Cockcroft-Gault equation.
Total bilirubin <=1.5*ULN except in participants with Gilbert's syndrome. Participants with Gilbert's syndrome may enroll if direct bilirubin <=1.5*ULN of the direct bilirubin.
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=2.5*ULN.
Participants must have recovered to Grade 1 toxicity from prior cancer therapy (a participant with Grade 2 neuropathy or Grade 2 alopecia is an exception to this criterion and may qualify for this study).
Participant able to take oral medications.
Participant meets the following criteria:
Female participant (of childbearing potential) is not breastfeeding, has a negative serum pregnancy test within 72 hours prior to taking study drug, and agrees to abstain from activities that could result in pregnancy from Screening through 180 days after the last dose of study drug, or is of non-childbearing potential.
Female participant is of non-childbearing potential (other than medical reasons) as defined:
>=45 years of age and has not had menses for >1 year. ii) Amenorrheic for <2 years without a hysterectomy and oophorectomy and a follicle-stimulating hormone value in the postmenopausal range upon the screening evaluation.
Has undergone post hysterectomy, bilateral oophorectomy, or tubal ligation. Documented hysterectomy, oophorectomy or tubal ligation must be confirmed in the medical records, otherwise the participant must be willing to use 2 adequate barrier methods throughout the study starting from the screening visit through 180 days after the last dose of study drug. Information must be captured appropriately within the site's source documents.
Male participant agrees to use an effective method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
Able to understand the study procedures and agree to participate in the study by providing written informed consent.

Who cannot join

Prior anti-cancer therapies for current malignancy.
Known evidence of distant metastasis. Staging studies are not required. The decision to pursue staging studies is at the discretion of the treating clinician, based on the participant's clinical and pathological findings consistent with standard guidelines.
Known hypersensitivity to the components of niraparib components or their formulation excipients.
Major surgery within 3 weeks of starting the study or participant has not recovered from any effects of any major surgery.
Poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, uncontrolled hypertension, active uncontrolled coagulopathy, bleeding disorder, or any psychiatric disorder that prohibits obtaining informed consent.
History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study drug, or is not in the best interest of the participant to participate.

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Participant is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the study drug or within the 180-day period after the last dose of study drug.
Immunocompromised participants.
Known active hepatic disease (Hepatitis B or C).
Prior treatment with a known PARP inhibitor.
Other active malignancy that warrants systemic therapy.
Known history of myelodysplastic syndromes (MDS) or Acute myeloid leukemia (AML).

About this study

Official title: An Open-Label, Single-arm Pilot Study Evaluating the Antitumor Activity and Safety of Niraparib as Neoadjuvant Treatment in Localized, HER2-negative, BRCA-mutant Breast Cancer Patients

This is an open-label, single-arm pilot study evaluating the antitumor activity and safety of niraparib as neoadjuvant therapy in participants with Human epidermal growth factor receptor 2 (HER2)-negative and breast cancer susceptibility gene mutant (BRCAmut) localized breast cancer (primary tumor >=1 centimeters [cm]). Breast magnetic resonance imaging (MRI), breast ultrasound, and tumor core biopsy will be performed at the screening (Days -28 to -1). Participants will receive niraparib (200 milligrams [mg] orally [PO]) treatment daily for 28 days (Cycle 1) and then will undergo breast ultrasound at the end of Cycle 1 on Day 28. Based on breast ultrasound reports, the participants will either discontinue the study (disease progression) or will continue niraparib treatment (complete response [CR], partial response [PR] or stable disease [SD]) for an additional cycle (Cycle 2). A breast MRI and breast ultrasound will be performed at the end of Cycle 2. Approximately 21 participants will be enrolled in this study and the study duration will be approximately 2 years.

Conditions: Neoplasms, Breast
Being tested: Niraparib
Keywords: Niraparib, Human epidermal growth factor receptor, Breast cancer, Breast ultrasound, Magnetic resonance imaging
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 is a potent, orally active, highly selective poly adenosine diphosphate ([ADP]-ribose) polymerase 1 (PARP1) and PARP2 inhibitor. It will be supplied as 100 mg capsules and will be administered at starting dose of 200 mg PO daily throughout 28 days for 2 cycles (each cycle is 28 days), with the potential for an additional 4 cycles (maximum total of 6 cycles) at the assigned dose and schedule.

Study groups in NCT03329937
Study group	Role	What they receive
Participants with HER2-negative and BRCAmut breast cancer	Experimental	Participants with HER2-negative and BRCAmut localized breast cancer (primary tumor >=1 cm) will receive niraparib (200 mg PO). Receives: Drug: Niraparib

What is being measured

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

Percentage of Participants With Tumor Response Measured by Breast MRI
Tumor response measured by breast MRI is defined as >=30 percent (%) reduction of tumor volume from Baseline based on primary lesion after niraparib treatment without any new lesion development. Tumor volume was calculated as (length × width × height × pi [π])/6. Responses were assessed as Clinical complete response (CR): A complete disappearance of all tumor signs in the breast as assessed by imaging test. Clinical partial response (PR): A reduction in the tumor volume of the primary tumor size by >=30% assessed by palpation or imaging test. Clinical stable disease (SD): No significant change in tumor volume during treatment. Clinical progressive disease (cPD): The development of new, previously undetected lesions, or an estimated increase in the size of the primary lesion by greater than 20%. Percentage of participants with tumor response and its 95 percent confidence interval (CI) has been presented. The 95% CI was the binomial exact CI based on Clopper-Pearson method.
Measured: At 2 months

Secondary outcomes (5)

Percentage of Participants With Pathological Complete Response (pCR)
pCR is defined as ypT0/Tis ypN0 by receipt of pre-operative chemotherapy (Yes versus No). Following neoadjuvant therapy, pathological staging is recorded using the 'yp' designation. ypT0/Tis ypN0 is the absence of invasive cancer in the breast and axillary nodes. pCR is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (i.e., ypT0/Tis ypN0 in the current American Joint Committee on Cancer [AJCC] staging system). Percentage of participants with pCR rate its 95 percent CI has been presented. CI was based on binomial exact CI.
Measured: Up to 1 year
Percentage of Participants With Tumor Response as Measured by Breast Ultrasound
Tumor response rate was based on the change in tumor volume as measured by breast ultrasound; a response was considered >=30 percent reduction of tumor volume from Baseline without any new lesion development. Tumor volume was calculated as (length × width × height × π)/6. Percentage of participants with tumor response and its 95 percent CI has been presented. CI was based on binomial exact CI.
Measured: Up to 6 months
Percent Change From Baseline in Tumor Volume Measured by Ultrasound
Percentage change in tumor volume from Baseline was measured using ultrasound. Baseline was defined as the most recent measurement prior to the first administration of niraparib. Tumor volume was calculated as (length × width × height × π)/6. The percentage reduction in tumor volume was set as 99% if the tumor becomes too small to measure at the post-baseline visit. Percent change from Baseline was defined as greatest change in volume, derived from all available cycles of niraparib (range from cycle 2 to 6) and multiplied by 100.
Measured: Baseline and up to 6 months
Percent Change From Baseline in Tumor Volume Measured by MRI
Percentage change in tumor volume from Baseline after 2 months of niraparib treatment was measured using MRI. Baseline was defined as the most recent measurement prior to the first administration of niraparib. Tumor volume was calculated as (length × width × height × π)/6. The percentage reduction in tumor volume was set as 99% if the tumor becomes too small to measure at the post-baseline visit. Percent change from Baseline was defined as value of post Baseline minus Baseline value and multiplied by 100.
Measured: Baseline and at 2 months
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Treatment Discontinuations and Dose Reductions Due to Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or an important medical event. A TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment.
Measured: Up to 1 year

Timeline

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

12 Apr 201831 Mar 2020

First posted6 Nov 2017
Study start12 Apr 2018
Primary completion2 Jan 2020
Study completion31 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Neoplasms, BreastStudies of the same condition, open and under way.
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 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03329937
Sponsor's protocol ID: 213355
Other IDs: 3000-01-005
Status last verified: Dec 2024
First submitted: 20 Oct 2017
Last updated: 8 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: GSK will assess requests from qualified researchers for anonymized individual patient-level data (IPD) and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf

Publications

Spring LM, Han H, Liu MC, Hamilton E, Irie H, Santa-Maria CA, Reeves J, Pan P, Shan M, Tang Y, Graham JR, Hazard S, Ellisen LW, Isakoff SJ. Neoadjuvant study of niraparib in patients with HER2-negative, BRCA-mutated, resectable breast cancer. Nat Cancer. 2022 Aug;3(8):927-931. doi: 10.1038/s43018-022-00400-2. Epub 2022 Jul 4.
PubMed 35788722

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Single-arm Pilot Study Evaluating the Antitumor Activity and Safety of Niraparib as Neoadjuvant Treatment in Localized, HER2-negative, BRCA-mutant Breast Cancer Patients
ClinicalTrials.gov ID: NCT03329937
Acronym / sponsor ID: 213355
Conditions: Neoplasms, Breast
Keywords: Niraparib, Human epidermal growth factor receptor, Breast cancer, Breast ultrasound, Magnetic resonance imaging
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Tesaro, Inc.Industry (pharma, biotech, devices)
Study start: 12 Apr 2018 (actual)
Primary completion: 2 Jan 2020 (actual)
Study completion: 31 Mar 2020 (actual)
First posted: 6 Nov 2017 (actual)
Results: Posted 12 Jan 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Participants with HER2-negative and BRCAmut breast cancer	Experimental	Drug: NiraparibParticipants with HER2-negative and BRCAmut localized breast cancer (primary tumor >=1 cm) will receive niraparib (200 mg PO).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (23 listed)

Participants age >= 18 years old.
Participants with a deleterious or suspected deleterious breast cancer susceptibility gene 1 (BRCA1) or BRCA2 mutation (germline or somatic) may be enrolled into the study based on either local or central laboratory testing of BRCA status.
Histologically-confirmed HER2-negative localized breast cancer by core biopsy.
Primary operable, non-metastatic invasive carcinoma of the breast, confirmed histologically by core biopsy. Fine-needle aspiration is not sufficient. Incisional biopsy is not allowed. In participants with multifocal and/or multicentric, the largest lesion should be measured. Both unilateral and bilateral breast cancer are allowed.
Primary tumor size >=1cm.

Key exclusion criteria (12 listed)

Prior anti-cancer therapies for current malignancy.
Known evidence of distant metastasis. Staging studies are not required. The decision to pursue staging studies is at the discretion of the treating clinician, based on the participant's clinical and pathological findings consistent with standard guidelines.
Known hypersensitivity to the components of niraparib components or their formulation excipients.
Major surgery within 3 weeks of starting the study or participant has not recovered from any effects of any major surgery.
Poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, uncontrolled hypertension, active uncontrolled coagulopathy, bleeding disorder, or any psychiatric disorder that prohibits obtaining informed consent.

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 is a potent, orally active, highly selective poly adenosine diphosphate ([ADP]-ribose) polymerase 1 (PARP1) and PARP2 inhibitor. It will be supplied as 100 mg capsules and will be administered at starting dose of 200 mg PO daily throughout 28 days for 2 cycles (each cycle is 28 days), with the potential for an additional 4 cycles (maximum total of 6 cycles) at the assigned dose and schedule.	Drug	Participants with HER2-negative and BRCAmut breast cancer

Primary outcome

Percentage of Participants With Tumor Response Measured by Breast MRI
Time frame: At 2 months
Tumor response measured by breast MRI is defined as >=30 percent (%) reduction of tumor volume from Baseline based on primary lesion after niraparib treatment without any new lesion development. Tumor volume was calculated as (length × width × height × pi [π])/6. Responses were assessed as Clinical complete response (CR): A complete disappearance of all tumor signs in the breast as assessed by imaging test. Clinical partial response (PR): A reduction in the tumor volume of the primary tumor size by >=30% assessed by palpation or imaging test. Clinical stable disease (SD): No significant change in tumor volume during treatment. Clinical progressive disease (cPD): The development of new, previously undetected lesions, or an estimated increase in the size of the primary lesion by greater than 20%. Percentage of participants with tumor response and its 95 percent confidence interval (CI) has been presented. The 95% CI was the binomial exact CI based on Clopper-Pearson method.

5 secondary outcomes

Percentage of Participants With Pathological Complete Response (pCR)
Time frame: Up to 1 year
Percentage of Participants With Tumor Response as Measured by Breast Ultrasound
Time frame: Up to 6 months
Percent Change From Baseline in Tumor Volume Measured by Ultrasound
Time frame: Baseline and up to 6 months
Percent Change From Baseline in Tumor Volume Measured by MRI
Time frame: Baseline and at 2 months
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Treatment Discontinuations and Dose Reductions Due to Adverse Events (AEs)
Time frame: Up to 1 year

Results and safety

Results posted to the registry on 12 Jan 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Niraparib 200 mg	21	21

Primary outcome: Percentage of Participants With Tumor Response Measured by Breast MRI

Time frame: At 2 months. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Niraparib 200 mg n = 21
Value	90.5 (69.6 to 98.8)

Population analysed: Efficacy Evaluable Population. The efficacy evaluable population consisted of all participants who completed 2 cycles of treatment.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 1 year. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Niraparib 200 mg	2 of 21 (9.5%)	21 of 21 (100%)	0 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 35788722Spring LM, Han H, Liu MC, Hamilton E, Irie H, Santa-Maria CA, Reeves J, Pan P, Shan M, Tang Y, Graham JR, Hazard S, Ellisen LW, Isakoff SJ. Neoadjuvant study of niraparib in patients with HER2-negative, BRCA-mutated, resectable breast cancer. Nat Cancer. 2022 Aug;3(8):927-931. doi: 10.1038/s43018-022-00400-2. Epub 2022 Jul 4.
Individual participant dataSharing planned: Yes. GSK will assess requests from qualified researchers for anonymized individual patient-level data (IPD) and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf

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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.

GSK Clinical Trials study director

GlaxoSmithKline

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Niraparib in people with Neoplasms, Breast, run by Tesaro, Inc..

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 12 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: finished, as of the sponsor's last update on 8 Jan 2025. 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 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.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With Tumor Response Measured by Breast MRI (time frame: At 2 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 NCT03329937, which also lists 1 linked publication.

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 8 Jan 2025.