Breast Neoplasms, Triple-NegativePhase 1RadioPARPNCT03109080
Olaparib & Radiation Therapy for Patients Triple Negative Breast Cancer (TNBC)
A Phase 1 study testing Olaparib and Radiation therapy in people with Breast Neoplasms, Triple-Negative and Breast Neoplasm Malignant Female, run by Institut Curie at 1 site in France.
Trial summary
A Phase I of Olaparib with Radiation Therapy in Patients With Inflammatory, Loco-regionally Advanced or Metastatic TNBC (triple negative breast cancer) or Patient With Operated TNBC with Residual Disease. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms, Triple-Negative, Breast Neoplasm Malignant Female, Radiotherapy Side Effect
- What is being tested?
- Olaparib and Radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jul 2017to 29 Nov 2021
- Phase
- Phase 1
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Woman aged >18 years.
- Histologically confirmed triple negative breast cancer with loco-regional radiotherapy indication :
- Non-operated with either:
- Inflammatory breast cancer in progression during neoadjuvant chemotherapy or inoperable after neoadjuvant chemotherapy.
- Loco-regional advanced breast cancer in progression during neoadjuvant chemotherapy or inoperable after neoadjuvant chemotherapy (T ≥ 3 and/or N ≥ 1; with evaluable disease according to RECIST 1.1 criteria).
- Non operable metastatic breast cancer (all T, all N, M1; with evaluable disease according to RECIST 1.1 criteria) needing local and regional treatment in case of good metastatic control after chemotherapy.
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- Or patient operated after neoadjuvant treatment and surgery with residual disease (non-pCR and/or pN+ disease).
- Neoadjuvant chemotherapy (containing anthracyclines or taxanes or the combination of both or containing platinum-based chemotherapy) willingness to discontinue any cytotoxic chemotherapeutic agents, immunotherapy, and targeted therapies at least two weeks prior to start of Olaparib.
- ECOG performance status < 2.
- Life expectancy greater than 6 months.
- Adequate hematologic, renal and hepatic function (assessed within the two weeks prior to registration and within the month prior to the commencement of protocol treatment). For patients who have stopped chemotherapy two weeks prior to protocol treatment, hematologic function must be re-assessment 1 or 2 days before the first Olaparib intake:
- Haemoglobin ≥ 10.0 g/dL.
- Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L.
- White Blood Cells (WBC) > 3 x 109/L.
- Platelet count ≥ 100 x 109/L.
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (except in case of Gilbert syndrome).
- AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case it must be ≤ 5 x ULN.
- Patients must have Creatinine Clearance estimated using the Cockcroft-Gault equation of ≥ 51 mL/min
- Urine or serum negative pregnancy test within two weeks prior to registration for non-postmenopausal patients. Negative pregnancy test confirmed within 1 or 2 days prior to first Olaparib intake.
- For woman with child-bearing potential, an efficacious contraception following sponsor recommendations must be used during the whole treatment period and up to three months after the last Olaparib administration.
- Ability to swallow and retain oral medications without gastrointestinal disorders likely to interfere with absorption of the study medication.
- Affiliation to the French Social Security System.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Radiation therapy: prior history of radiation therapy to the ipsilateral breast and/or regional nodes (except prior radiation therapy to other sites).
- Patient with unresolved or unstable, NCI-CTCAE v4.03 (National Cancer Institute Common Toxicity Criteria for Adverse Events) Grade 3 or greater toxicity from prior administration of prior anti-cancer treatment.
- Patient with clinically and uncontrolled significant comorbidity: major cardiac, respiratory, renal, hepatic, gastrointestinal, hematologic or neurological/psychiatric disease or disorder, including but not limited to: active uncontrolled infection; symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia; any other illness condition(s) that could exacerbate potential toxicities, require excluded therapy for management, or limit compliance with study requirements.
- Patient with second primary cancer, except : adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years.
- Concomitant anti-cancer treatment during protocol treatment and/or not completed at least 2 weeks prior to Olaparib initiation, except bisphosphonates and RANK inhibitors without restriction even during protocol treatment as long as these where started at least 4 weeks prior to study treatment initiation.
- Any previous treatment with a PARP (Poly (Adenosine diphosphate [ADP]-Ribose) Polymerase) inhibitor, including Olaparib.
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- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Olaparib.
- Patient being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A (Rifabutin, Rifampicin, Clarithromycin, Ketoconazole, Itraconazole, Voriconazole, Ritonavir, Telithromycin) within the last 7 days before first Olaparib intake.
- Resting ECG with QTc > 470 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome.
- Blood transfusions within 14 days prior to treatment start.
- Patient with myelodysplastic syndrome / acute myeloid leukaemia.
- Pregnant or breastfeeding woman.
- Patient already included in another clinical trial with an investigational drug.
- Patient individually deprived of liberty or placed under the authority of a tutor.
- Patient with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I of Olaparib With Radiation Therapy in Patients With Inflammatory, Loco-regionally Advanced or Metastatic TNBC (Triple Negative Breast Cancer) or Patient With Operated TNBC With Residual Disease
A Phase I of Olaparib with Radiation Therapy in Patients With Inflammatory, Loco-regionally Advanced or Metastatic TNBC (triple negative breast cancer) or Patient With Operated TNBC with Residual Disease.
Read the detailed description
Open label phase I, dose escalation trial for patients with triple negative inflammatory, loco-regional advanced or metastatic breast cancer either inoperable after neoadjuvant chemotherapy or operated with residual disease (after neoadjuvant chemotherapy).
- Conditions
- Breast Neoplasms, Triple-Negative, Breast Neoplasm Malignant Female, Radiotherapy Side Effect
- Being tested
- Olaparib, Radiation therapy
- Medical subject headings
- Triple Negative Breast Neoplasms, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlaparibDrug
Also called PARP (Poly (Adenosine diphosphate [ADP]-Ribose) Polymerase) inhibitor, Lynparza, AZD-2281
five levels of dose, per os administration, twice daily each day
Radiation therapyRadiation
Also called Radiotherapy
3D conformal radiotherapy or intensity-modulated radiotherapy (IMRT), Simultaneous Integrated Boost (SIB), postoperative radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Olaparib + radiation therapy | Experimental | One week of Olaparib alone followed by 5 weeks of Olaparib and concurrent loco-regional radiotherapy. Five levels of dose of Olaparib are expected. Receives: Drug: Olaparib; Radiation: Radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the Maximal Tolerated Dose of Olaparib administered with concurrent loco regional radiotherapy
Incidence of early Dose Limited Toxicity (DLTs: early adverse effects related to Olaparib administered with concurrent radiotherapy) to determinate the Maximal Tolerated Dose (MTD) of Olaparib administered with concurrent loco regional radiotherapy in patients who have triple negative inflammatory, loco-regional advanced or metastatic breast cancer either inoperable after neoadjuvant chemotherapy or operated patient with residual disease (after neoadjuvant chemotherapy).
Measured: 2 years
Secondary outcomes (15)
Incidence of Serious Adverse Events (SAEs), graded according to NCI-CTCAE version 4.03 criteria to assess the safety profile of Olaparib administered with concurrent loco-regional radiotherapy.
Incidence of Serious Adverse Events (SAEs), graded according to NCI-CTCAE version 4.03 criteria
Measured: 2 years
Incidence and severity of Adverse Events (AEs), graded according to NCI-CTCAE version 4.03 criteria to assess the safety profile of Olaparib administered with concurrent loco-regional radiotherapy.
Incidence and severity of Adverse Events (AEs), graded according to NCI-CTCAE version 4.03 criteria
Measured: 2 years
Incidence and severity of laboratory abnormalities, graded according to NCI-CTCAE version 4.03 criteria to assess the safety profile of Olaparib administered with concurrent loco-regional radiotherapy.
Incidence and severity of laboratory abnormalities, graded according to NCI-CTCAE version 4.03 criteria
Measured: 2 years
Incidence of acute toxicity 2 weeks and 6 weeks after the end of radiotherapy to assess the safety profile of Olaparib administered with concurrent loco-regional radiotherapy.
Incidence of acute toxicity 2 weeks and 6 weeks after the end of radiotherapy
Measured: 2 years
Incidence of late toxicity at 1 year and at 2 years as of initiation of radiation therapy to assess the safety profile of Olaparib administered with concurrent loco-regional radiotherapy.
Incidence of late toxicity at 1 year and at 2 years as of initiation of radiation therapy
Measured: 2 years
Incidence of treatment discontinuations and treatment modifications due to AEs to assess the safety profile of Olaparib administered with concurrent loco-regional radiotherapy.
Incidence of treatment discontinuations and treatment modifications due to AEs
Measured: 2 years
Evaluation of the Objective Response Rate (ORR) to evaluate Olaparib administered with concurrent loco regional radiotherapy efficacy profile
Evaluation of the Objective Response Rate (ORR) to treatment
Measured: 2 years
Evaluation of the Complete Response Rate to evaluate Olaparib administered with concurrent loco regional radiotherapy efficacy profile
Evaluation of the Complete Response Rate to treatment
Measured: 2 years
Evaluation of Pathological Response Rate (pRR) after salvage surgery to evaluate Olaparib administered with concurrent loco regional radiotherapy efficacy profile
Evaluation of Pathological Response Rate (pRR) after salvage surgery
Measured: 2 years
Evaluation of the loco-regional Progression Free Survival (l-PFS) to evaluate Olaparib administered with concurrent loco regional radiotherapy efficacy profile
Evaluation of the loco-regional Progression Free Survival (l-PFS)
Measured: 2 years
Evaluation of the Progression Free Survival (PFS) or Disease Free survival (DFS) according to stage of disease to evaluate patient outcome
Evaluation of the Progression Free Survival (PFS) or Disease Free survival (DFS)
Measured: 2 years
Evaluation of the distant relapse rate to evaluate patient outcome
Evaluation of the distant relapse rate
Measured: 2 years
Evaluation of patient outcome by evaluation of the Overall Survival (OS).
Evaluation Overall Survival (OS).
Measured: 2 years
Evaluation of patient outcome by evaluate disease specific survival rate.
Evaluation of the disease specific survival rate.
Measured: 2 years
Explore biomarkers of Olaparib activity in combination with concurrent radiotherapy.
Exploration of biomarkers of Olaparib associated with radiotherapy on biopsies.
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 posted12 Apr 2017
- Study start24 Jul 2017
- Primary completion17 Feb 2020
- Study completion29 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast Neoplasms, Triple-NegativeStudies 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Youlia KIROVA, MD, Study director, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03109080
- Sponsor's protocol ID
- IC 2016-01 RadioPARP
- Other IDs
- 2016-001837-28, 2016
- Acronym
- RadioPARP
- Status last verified
- Nov 2025
- First submitted
- 2 Mar 2017
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Publications
Loap P, Loirat D, Berger F, Ricci F, Vincent-Salomon A, Ezzili C, Mosseri V, Fourquet A, Ezzalfani M, Kirova Y. Combination of Olaparib and Radiation Therapy for Triple Negative Breast Cancer: Preliminary Results of the RADIOPARP Phase 1 Trial. Int J Radiat Oncol Biol Phys. 2021 Feb 1;109(2):436-440. doi: 10.1016/j.ijrobp.2020.09.032. Epub 2020 Sep 21.
PubMed 32971187Loap P, Loirat D, Berger F, Rodrigues M, Bazire L, Pierga JY, Vincent-Salomon A, Laki F, Boudali L, Raizonville L, Mosseri V, Jochem A, Eeckhoutte A, Diallo M, Stern MH, Fourquet A, Kirova Y. Concurrent Olaparib and Radiotherapy in Patients With Triple-Negative Breast Cancer: The Phase 1 Olaparib and Radiation Therapy for Triple-Negative Breast Cancer Trial. JAMA Oncol. 2022 Dec 1;8(12):1802-1808. doi: 10.1001/jamaoncol.2022.5074.
PubMed 36301572
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I of Olaparib With Radiation Therapy in Patients With Inflammatory, Loco-regionally Advanced or Metastatic TNBC (Triple Negative Breast Cancer) or Patient With Operated TNBC With Residual Disease
- ClinicalTrials.gov ID
- NCT03109080
- Acronym / sponsor ID
- RadioPARP / IC 2016-01 RadioPARP
- Conditions
- Breast Neoplasms, Triple-Negative, Breast Neoplasm Malignant Female, Radiotherapy Side Effect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 24 Jul 2017 (actual)
- Primary completion
- 17 Feb 2020 (actual)
- Study completion
- 29 Nov 2021 (actual)
- First posted
- 12 Apr 2017 (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.
A Phase I of Olaparib with Radiation Therapy in Patients With Inflammatory, Loco-regionally Advanced or Metastatic TNBC (triple negative breast cancer) or Patient With Operated TNBC with Residual Disease.
Detailed description
Open label phase I, dose escalation trial for patients with triple negative inflammatory, loco-regional advanced or metastatic breast cancer either inoperable after neoadjuvant chemotherapy or operated with residual disease (after neoadjuvant chemotherapy).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Olaparib + radiation therapy | Experimental | Drug: Olaparib, Radiation: Radiation therapyOne week of Olaparib alone followed by 5 weeks of Olaparib and concurrent loco-regional radiotherapy. Five levels of dose of Olaparib are expected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Woman aged >18 years.
- Histologically confirmed triple negative breast cancer with loco-regional radiotherapy indication :
- Neoadjuvant chemotherapy (containing anthracyclines or taxanes or the combination of both or containing platinum-based chemotherapy) willingness to discontinue any cytotoxic chemotherapeutic agents, immunotherapy, and targeted therapies at least two weeks prior to start of Olaparib.
- ECOG performance status < 2.
- Life expectancy greater than 6 months.
Key exclusion criteria (15 listed)
- Radiation therapy: prior history of radiation therapy to the ipsilateral breast and/or regional nodes (except prior radiation therapy to other sites).
- Patient with unresolved or unstable, NCI-CTCAE v4.03 (National Cancer Institute Common Toxicity Criteria for Adverse Events) Grade 3 or greater toxicity from prior administration of prior anti-cancer treatment.
- Patient with clinically and uncontrolled significant comorbidity: major cardiac, respiratory, renal, hepatic, gastrointestinal, hematologic or neurological/psychiatric disease or disorder, including but not limited to: active uncontrolled infection; symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia; any other illness condition(s) that could exacerbate potential toxicities, require excluded therapy for management, or limit compliance with study requirements.
- Patient with second primary cancer, except : adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years.
- Concomitant anti-cancer treatment during protocol treatment and/or not completed at least 2 weeks prior to Olaparib initiation, except bisphosphonates and RANK inhibitors without restriction even during protocol treatment as long as these where started at least 4 weeks prior to study treatment initiation.
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 |
|---|---|---|
| OlaparibAlso: PARP (Poly (Adenosine diphosphate [ADP]-Ribose) Polymerase) inhibitor, Lynparza, AZD-2281five levels of dose, per os administration, twice daily each day | Drug | Olaparib + radiation therapy |
| Radiation therapyAlso: Radiotherapy3D conformal radiotherapy or intensity-modulated radiotherapy (IMRT), Simultaneous Integrated Boost (SIB), postoperative radiotherapy | Radiation | Olaparib + radiation therapy |
Primary outcome
Determination of the Maximal Tolerated Dose of Olaparib administered with concurrent loco regional radiotherapy
Time frame: 2 years
Incidence of early Dose Limited Toxicity (DLTs: early adverse effects related to Olaparib administered with concurrent radiotherapy) to determinate the Maximal Tolerated Dose (MTD) of Olaparib administered with concurrent loco regional radiotherapy in patients who have triple negative inflammatory, loco-regional advanced or metastatic breast cancer either inoperable after neoadjuvant chemotherapy or operated patient with residual disease (after neoadjuvant chemotherapy).
15 secondary outcomes
Incidence of Serious Adverse Events (SAEs), graded according to NCI-CTCAE version 4.03 criteria to assess the safety profile of Olaparib administered with concurrent loco-regional radiotherapy.
Time frame: 2 years
Incidence and severity of Adverse Events (AEs), graded according to NCI-CTCAE version 4.03 criteria to assess the safety profile of Olaparib administered with concurrent loco-regional radiotherapy.
Time frame: 2 years
Incidence and severity of laboratory abnormalities, graded according to NCI-CTCAE version 4.03 criteria to assess the safety profile of Olaparib administered with concurrent loco-regional radiotherapy.
Time frame: 2 years
Incidence of acute toxicity 2 weeks and 6 weeks after the end of radiotherapy to assess the safety profile of Olaparib administered with concurrent loco-regional radiotherapy.
Time frame: 2 years
Incidence of late toxicity at 1 year and at 2 years as of initiation of radiation therapy to assess the safety profile of Olaparib administered with concurrent loco-regional radiotherapy.
Time frame: 2 years
Incidence of treatment discontinuations and treatment modifications due to AEs to assess the safety profile of Olaparib administered with concurrent loco-regional radiotherapy.
Time frame: 2 years
Evaluation of the Objective Response Rate (ORR) to evaluate Olaparib administered with concurrent loco regional radiotherapy efficacy profile
Time frame: 2 years
Evaluation of the Complete Response Rate to evaluate Olaparib administered with concurrent loco regional radiotherapy efficacy profile
Time frame: 2 years
Evaluation of Pathological Response Rate (pRR) after salvage surgery to evaluate Olaparib administered with concurrent loco regional radiotherapy efficacy profile
Time frame: 2 years
Evaluation of the loco-regional Progression Free Survival (l-PFS) to evaluate Olaparib administered with concurrent loco regional radiotherapy efficacy profile
Time frame: 2 years
Evaluation of the Progression Free Survival (PFS) or Disease Free survival (DFS) according to stage of disease to evaluate patient outcome
Time frame: 2 years
Evaluation of the distant relapse rate to evaluate patient outcome
Time frame: 2 years
Evaluation of patient outcome by evaluation of the Overall Survival (OS).
Time frame: 2 years
Evaluation of patient outcome by evaluate disease specific survival rate.
Time frame: 2 years
Explore biomarkers of Olaparib activity in combination with concurrent radiotherapy.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Results publication: PubMed 32971187Loap P, Loirat D, Berger F, Ricci F, Vincent-Salomon A, Ezzili C, Mosseri V, Fourquet A, Ezzalfani M, Kirova Y. Combination of Olaparib and Radiation Therapy for Triple Negative Breast Cancer: Preliminary Results of the RADIOPARP Phase 1 Trial. Int J Radiat Oncol Biol Phys. 2021 Feb 1;109(2):436-440. doi: 10.1016/j.ijrobp.2020.09.032. Epub 2020 Sep 21.
- Derived from this study: PubMed 36301572Loap P, Loirat D, Berger F, Rodrigues M, Bazire L, Pierga JY, Vincent-Salomon A, Laki F, Boudali L, Raizonville L, Mosseri V, Jochem A, Eeckhoutte A, Diallo M, Stern MH, Fourquet A, Kirova Y. Concurrent Olaparib and Radiotherapy in Patients With Triple-Negative Breast Cancer: The Phase 1 Olaparib and Radiation Therapy for Triple-Negative Breast Cancer Trial. JAMA Oncol. 2022 Dec 1;8(12):1802-1808. doi: 10.1001/jamaoncol.2022.5074.
- Individual participant dataSharing planned: Yes. Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
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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.
Youlia KIROVA, MD study director
Institut Curie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Olaparib and Radiation therapy in people with Breast Neoplasms, Triple-Negative and Breast Neoplasm Malignant Female, run by Institut Curie at 1 site in France.
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 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: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Determination of the Maximal Tolerated Dose of Olaparib administered with concurrent loco regional radiotherapy (time frame: 2 years). 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 NCT03109080, which also lists 2 linked publications.
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 24 Nov 2025.