Triple Negative Breast CancerPhase 1UNITYNCT03945721
A Phase I Study of Niraparib Administered Concurrently With Postoperative RT in Triple Negative Breast Cancer Patients
A Phase 1 study testing Niraparib and Radiation Therapy in people with Triple Negative Breast Cancer and Residual Disease, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
This research study involves Niraparib as a possible treatment for triple negative breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triple Negative Breast Cancer, Residual Disease
- What is being tested?
- Niraparib and Radiation Therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Jul 2019to 31 Dec 2028
- Phase
- Phase 1
- 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
- Males or Females, ≥ 18 years of age.
- Non-metastatic, histologically or cytologically-confirmed TNBC (defined as ER <1%, PR <1%, her-2-neu 0-1+ by IHC or FISH-negative or as per MD discretion).
- Definitive surgical treatment with breast-conserving surgery or mastectomy and axillary lymph node evaluation.
- Plans for receipt of postoperative radiation therapy to the breast/chest wall +/- regional nodes
- Residual invasive disease after NAC (any size), or at least 1.0 cm in patients who do not receive NAC and undergo surgery first.
- ECOG Performance status ≤ 1.
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- Willingness to discontinue any cytotoxic chemotherapeutic agents, immunotherapy and biologic therapy at least 2 weeks prior to the start of RT.
- Adequate organ function (assessed within 30 days prior to initiation of protocol treatment, unless otherwise indicated) as follows:
- Hematology
- Absolute Neutrophil Count (ANC) ≥1500/mm3
- Platelet Count ≥100,000/mm3
- Hemoglobin ≥9.0 g/dL
- Renal Function
- Creatinine Serum ≤ 1.5 mg/dL or
- Creatinine Clearance ≥ 45 mL/mina
- Hepatic Function
- Bilirubin ≤ 1.5 mg/dL
- Aspartate Aminotransferase (AST) ≤ 2.5 x ULNb
- Alanine Aminotransferase (ALT) ≤ 2.5 x ULN
- ULN = upper normal limit of institution's normal range
- If calculated creatinine clearance is < 45mL/min, a 24-hour urine collection for creatinine clearance may be performed
- Subjects with documented Gilbert's disease may have bilirubin up to 2.5 mg/dL
- Female participants have a negative urine or serum pregnancy test within 7 days prior to study treatment if a woman has child-bearing potential, and agrees to abstain from activities that could result in pregnancy from screening through 180 days after the last dose of study treatment, or is of non-childbearing potential.
- Non-childbearing potential is defined as follows (by other than medical reasons):
- --≥45 years of age and has not had menses for >1 year
- Patients who have been amenorrhoeic for <2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation
- Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure, otherwise the patient must be willing to use 2 adequate barrier methods throughout the study, starting with the screening visit through 180 days after the last dose of study treatment. See Section 5.6.4.5 for a list of acceptable birth control methods. Information must be captured appropriately within the site's source documents. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.
- Male participant agrees to use an adequate method of contraception (see Section 5.6.4.5) for a list of acceptable birth control methods) starting with the first dose of study treatment through 90 days after the last dose of study treatment. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.
- Participant must agree not to breastfeed during the study or for 30 days after the last dose of study treatment.
- Participant receiving corticosteroids may continue as long as their dose is stable for at least 4 weeks prior to initiating protocol therapy.
- Participant must agree not to donate blood during the study or for 90 days after the last dose of study treatment.
- Ability to swallow (whole) and retain oral medications.
- Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
- Dose Cohort 2 only:
- Actual body weight ≥77kg AND
- Platelet count ≥150,000 µL
Who cannot join
- Gross residual tumor or positive margins after surgery that is un-excised (excluding positive margins at the chest wall or skin where no additional breast tissue can be removed).
- pT1aN0 or pT1bN0 (primary tumor size <1.0 cm) triple negative breast cancer patients who do undergo neoadjuvant chemotherapy and receive surgery followed by +/- adjuvant chemotherapy.
- Receipt of PARP inhibitor at any time prior to study enrollment.
- Pregnant or expecting to conceive within the projected duration of the trial, starting with screening visit through 180 days after the last dose of trial treatment.
- Prior history of radiation therapy to the ipsilateral breast and/or regional nodes is not allowed (prior RT to other sites that was completed ≥ 1 week prior to Day 1 of protocol therapy, or if prior RT encompassed >20% of the bone marrow it was completed ≥ 2 weeks prior to Day 1 of protocol therapy, is permitted).
- Major surgery ≤ 3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects.
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- History of allergic reactions attributed to compounds of similar chemical or biologic composition to niraparib, or its components or excipients.
- Concomitant anti-neoplastic treatment is not allowed during protocol treatment and should be completed at least 2 weeks prior to commencement of protocol treatment, with resolution of associated acute toxicities. Bisphosphonates are permitted without restriction even during protocol treatment.
- Significant comorbidity: Patients with clinically significant and uncontrolled major disease or disorder that could exacerbate potential toxicities, confound safety assessments, require excluded therapy for management, or limit study compliance.
- Treatment with investigational therapy within ≤ 4 weeks, or within a time interval less than at least five half-lives of the investigational agent, whichever is shorter, prior to initiating protocol therapy. Patients may not be simultaneously enrolled in any interventional clinical trial.
- Unresolved toxicity from other agents. Patients with unresolved CTCAE v5 Grade 2 or greater toxicity, with the exception of alopecia and anemia, from prior administration of another investigational drug and/or anti-cancer treatment are not eligible.
- Known grade 3 or 4 anemia, neutropenia, or thrombocytopenia that persisted > 4 weeks and was related to the most recent chemotherapy treatment.
- Participant must not have received a transfusion (platelets or red blood cells) ≤ 4 weeks prior to initiating protocol therapy.
- Participant must not have received colony-stimulating factors (e.g. granulocyte colony-stimulating factor, granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) within 4 weeks prior to initiating protocol therapy.
- Prior malignancy within 5 years of study enrollment.
- Scleroderma and systemic lupus erythematosis.
- Known p53 germline mutations.
- Known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
- Known symptomatic brain or leptomeningeal metastases.
- Dose Cohort 2 only:
- Actual body weight < 77kg OR
- Platelet count < 150,000 µL
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Dana Farber Cancer Institute/Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: A Phase I Study of Niraparib Administered Concurrently With Postoperative RT in Triple Negative Breast Cancer Patients (UNITY)
This research study involves Niraparib as a possible treatment for triple negative breast cancer.
Read the detailed description
This research study is a Phase I clinical trial, which tests the safety of an investigational drug and also tries to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is being studied.
The FDA (the U.S. Food and Drug Administration) has not approved niraparib for this specific disease but it has been approved for other uses.
Niraparib is a type of drug called a "PARP inhibitor", which blocks DNA (the genetic material of cells) damage from being repaired or may prevent damage from occurring in the first place. In cancer treatment, inhibiting PARP may help kill cancer cells by not allowing the cancer cells to repair its DNA damage or prevent DNA damage from occurring.
This trial is studying people who have triple negative breast cancer because this cancer type is shown to have DNA repair mechanisms that may benefit from combined PARP inhibitor and radiation, and may help prevent recurrence of cancers in the chest wall and lymph nodes of the affected side.
- Conditions
- Triple Negative Breast Cancer, Residual Disease
- Being tested
- Niraparib, Radiation Therapy
- Keywords
- Breast Cancer, Triple Negative, Locally Advanced
- Medical subject headings
- Triple Negative Breast Neoplasms, Neoplasm, Residual, 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 type of drug called a "PARP inhibitor", which blocks DNA (the genetic material of cells) damage from being repaired or may prevent damage from occurring in the first place. In cancer treatment, inhibiting PARP may help kill cancer cells by not allowing the cancer cells to repair its DNA damage or prevent DNA damage from occurring.
Radiation TherapyRadiation
radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| Niraparib | Experimental | * Niraparib will be administered orally on a daily basis
* Radiation Therapy will be administered concurrently with Niraparib Receives: Drug: Niraparib; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose
The proportion of subjects tolerating each maximum dose level. The trial will be monitored using a 3+3 dose escalation method.
Measured: 10 weeks
Secondary outcomes (4)
Locoregional Relapse
The incidence of recurrence of breast cancer in the ipsilateral chest wall or regional lymph nodes will be captured
Measured: 2 years
Distant Relapse
The incidence of recurrence of breast cancer in regions outside of the ipsilateral chest wall or regional lymph nodes will be captured
Measured: 2 years
Treatment related adverse events
Adverse events will be assessed using common terminology criteria for adverse events (CTCAE) v5.
Measured: 2 Years
Breast cosmesis
Breast cosmesis will be assessed using the Radiation Therapy Oncology Group (ROTG) cosmesis assessment criteria. Brest cosmesis will be reported as the number of participants reporting excellent/good or fair/poor cosmetic results.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start11 Jul 2019
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (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 CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tesaro, Inc.
- Responsible party
- Principal investigator, Steven J Isakoff, MD, PhD, Massachusetts General Hospital
- Investigators
- Alice Ho, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03945721
- Sponsor's protocol ID
- 19-055
- Acronym
- UNITY
- Status last verified
- Jun 2026
- First submitted
- 29 Apr 2019
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Niraparib Administered Concurrently With Postoperative RT in Triple Negative Breast Cancer Patients (UNITY)
- ClinicalTrials.gov ID
- NCT03945721
- Acronym / sponsor ID
- UNITY / 19-055
- Conditions
- Triple Negative Breast Cancer, Residual Disease
- Keywords
- Breast Cancer, Triple Negative, Locally Advanced
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Tesaro, Inc.
- Study start
- 11 Jul 2019 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 10 May 2019 (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.
This research study involves Niraparib as a possible treatment for triple negative breast cancer.
Detailed description
This research study is a Phase I clinical trial, which tests the safety of an investigational drug and also tries to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is being studied.
The FDA (the U.S. Food and Drug Administration) has not approved niraparib for this specific disease but it has been approved for other uses.
Niraparib is a type of drug called a "PARP inhibitor", which blocks DNA (the genetic material of cells) damage from being repaired or may prevent damage from occurring in the first place. In cancer treatment, inhibiting PARP may help kill cancer cells by not allowing the cancer cells to repair its DNA damage or prevent DNA damage from occurring.
This trial is studying people who have triple negative breast cancer because this cancer type is shown to have DNA repair mechanisms that may benefit from combined PARP inhibitor and radiation, and may help prevent recurrence of cancers in the chest wall and lymph nodes of the affected side.
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: Niraparib, Radiation: Radiation Therapy* Niraparib will be administered orally on a daily basis * Radiation Therapy will be administered concurrently with Niraparib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (36 listed)
- Males or Females, ≥ 18 years of age.
- Non-metastatic, histologically or cytologically-confirmed TNBC (defined as ER <1%, PR <1%, her-2-neu 0-1+ by IHC or FISH-negative or as per MD discretion).
- Definitive surgical treatment with breast-conserving surgery or mastectomy and axillary lymph node evaluation.
- Plans for receipt of postoperative radiation therapy to the breast/chest wall +/- regional nodes
- Residual invasive disease after NAC (any size), or at least 1.0 cm in patients who do not receive NAC and undergo surgery first.
Key exclusion criteria (22 listed)
- Gross residual tumor or positive margins after surgery that is un-excised (excluding positive margins at the chest wall or skin where no additional breast tissue can be removed).
- pT1aN0 or pT1bN0 (primary tumor size <1.0 cm) triple negative breast cancer patients who do undergo neoadjuvant chemotherapy and receive surgery followed by +/- adjuvant chemotherapy.
- Receipt of PARP inhibitor at any time prior to study enrollment.
- Pregnant or expecting to conceive within the projected duration of the trial, starting with screening visit through 180 days after the last dose of trial treatment.
- Prior history of radiation therapy to the ipsilateral breast and/or regional nodes is not allowed (prior RT to other sites that was completed ≥ 1 week prior to Day 1 of protocol therapy, or if prior RT encompassed >20% of the bone marrow it was completed ≥ 2 weeks prior to Day 1 of protocol therapy, is permitted).
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 type of drug called a "PARP inhibitor", which blocks DNA (the genetic material of cells) damage from being repaired or may prevent damage from occurring in the first place. In cancer treatment, inhibiting PARP may help kill cancer cells by not allowing the cancer cells to repair its DNA damage or prevent DNA damage from occurring. | Drug | Niraparib |
| Radiation Therapyradiation therapy | Radiation | Niraparib |
Primary outcome
Maximum Tolerated Dose
Time frame: 10 weeks
The proportion of subjects tolerating each maximum dose level. The trial will be monitored using a 3+3 dose escalation method.
4 secondary outcomes
Locoregional Relapse
Time frame: 2 years
Distant Relapse
Time frame: 2 years
Treatment related adverse events
Time frame: 2 Years
Breast cosmesis
Time frame: 2 years
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 17 Jun 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
Enrolling by invitationPhase 1
A Study of ITC-6146RO in Patients With Advanced or Metastatic Cancer Who Have Failed Standard Therapy
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RecruitingPhase 2
Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer
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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.
Alice Ho, MD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Niraparib and Radiation Therapy in people with Triple Negative Breast Cancer and Residual Disease, run by Massachusetts General Hospital at 2 sites in United States.
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 36 inclusion and 22 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: under way, not looking for participants, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 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?
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?
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?
Maximum Tolerated Dose (time frame: 10 weeks). 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 17 Jun 2026.