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Breast CancerPhase 2NCT02681562

Olaparib in Locally Advanced ER, PgR and HER2 Negative (Triple Negative) and in Locally Advanced Germline BRCA Mutation-positive Breast Cancer Patients

A Phase 2 study testing olaparib in people with Breast Cancer and Triple Negative Breast Cancer, run by Istituti Ospitalieri di Cremona.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Treatment selection for breast cancer is still largely empiric and guided by large randomized clinical trials on populations of patients. This approach is inadequate for the selection of individualized chemotherapy regimens. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Breast Cancer, Triple Negative Breast Cancer
What is being tested?
olaparib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
No sites listed yet
Study dates
Jan 2016to Jan 2018
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 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provision of informed consent prior to any study specific procedures
  • Patients (female) must be 18 years of age.
  • Clinically or radiologically measurable or evaluable disease defined as: presence of bidimensionally or unidimensionally measurable breast lesion by physical or radiological examination.
  • Estrogen receptor < 10% for ARM A only
  • Progesterone receptor = 0 for ARM A only
  • HER2 negative on primary tumor (HER-2 score of 0 or 1+/2+ with FISH not amplified) for ARM A only
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  • Mutation of BRCA 1 and/or 2 for ARM B only
  • Germline BRCA1 or BRCA2 mutation that is considered deleterious or suspected deleterious (include those mutations or translocations termed "deleterious" or "suspected deleterious" according to lab reporting). Testing under the context of this protocol may be performed at any time prior to allocation.
  • Patients who have a prior BRCA test may be enrolled into the study based at the result of the prior test
  • Provision of informed consent for genetic research. If a patient declines to participate in the genetic research, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study described in this Clinical Study Protocol, so long as they consent to that part.
  • Patients must have normal organ and bone marrow function, ECOG performance status 0-1 (can be amended for specific populations studies)
  • Adequate cardiac function: left ventricular ejection fraction (LVEF) at rest measured by echocardiography must be no lower than the local normal limit.
  • Absence of clinically significant cardiovascular disease (e.g. myocardial infarction, unstable angina), New York Hearth Association (NYHA) grade II or greater congestive hearth failure, serious cardiac arrhythmia requiring medication, or grade II or greater peripheral vascular disease within 12 months prior to day 1 on study
  • Patients must have voluntarily agreed to participate by given informed consent. Written informed consent must be dated and signed by both patients and investigator

Who cannot join

  • Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
  • Previous enrolment in the present study
  • Participation in another clinical study with an investigational product during the last 12 months
  • Any previous treatment with a PARP inhibitor, including olaparib.
  • Patients receiving any systemic chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study treatment (or a longer period depending on the defined characteristics of the agents used). The patient can receive a stable dose of bisphosphonates for bone metastases, before and during the study as long as these were started at least 4 weeks prior to treatment with study drug.
  • Concomitant use of known CYP3A4 inhibitors such as ketokonazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir
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  • Blood transfusions within 1 month prior to study start
  • Patients with myelodysplastic syndrome/acute myeloid leukaemia.
  • Patients with-out any sign or symptoms of distant metastases.
  • Major surgery within 14 days of starting study treatment and patients must have recovered from any effects of any major surgery.

About this study

Official title: A Phase II, Open Label, Controlled Study of Olaparib in Locally Advanced ER, PgR and HER2 Negative (Triple Negative) and in Locally Advanced Germline BRCA Mutation-positive Breast Cancer Patients: Biological Evaluation From a "Window of Opportunity" Trial

Treatment selection for breast cancer is still largely empiric and guided by large randomized clinical trials on populations of patients. This approach is inadequate for the selection of individualized chemotherapy regimens. Estimates of benefits for individuals are extrapolations from the effects seen in these large trials, and do not necessarily apply to individual patients. The revolution in genomics promises to transform oncology care. By better defining cancer subtypes, a better understanding of breast cancer biology should help to guide treatment.

The up-front phase we have decide to adopt play a pivotal role as it is useful for testing a targeted therapeutic drug such as olaparib wich also requires development of new biomarkers which may be useful for future studies. With this approach it could be possible to demonstrate drug target or biomarker effect in clinical setting and models the relationship between the pharmacodynamics and the pharmacokinetics. Additional benefits of this approach include the following:

  • It could facilitate rational drug selection, identify therapeutic failures early, and compress timelines for anticancer drug development.
  • It could provide initial rationale and guiding principles for further drug development based on studies in humans (rather than xenografts, where tissues of one species are transplanted to another species).
  • As it focuses on extensively characterizing how a drug works and whether it hits its intended target (including molecular imaging studies) in a limited number of patients it could yield results that would optimally inform and expedite the subsequent development of molecularly-targeted agents
Being tested
olaparib
Keywords
olaparib
Medical subject headings
Breast Neoplasms, Triple Negative Breast Neoplasms

What participants receive

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

Study groups in NCT02681562
Study groupRoleWhat they receive
Olaparib triple negativeExperimentalOlaparib short administration in triple negative breast cancer
Receives: Drug: olaparib
Olaparib BRCA mutatedExperimentalOlaparib short administration in BRCA mutated patients
Receives: Drug: olaparib

What is being measured

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

  1. Correlation between baseline gene and protein expression profile and clinical response

    Measured: Duration of the study

Secondary outcomes (4)

  1. Assess overall response rate by RECIST criteria evaluated clinically in each treatment group

    Measured: Through study completion, an average of 1 year

  2. Evaluate safety and tolerability of olaparib alone assessed by CTCAE v4.0

    Measured: Through study completion, an average of 1 year

  3. Compare time to deterioration of health-related quality of life by QLQ-C30 scale

    Measured: Through study completion, an average of 1 year

  4. Compare health status by QLQ-C30 scale

    Measured: Through study completion, an average of 1 year

Timeline

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

  1. First posted12 Feb 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionJan 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02681562
Sponsor's protocol ID
ISS22810078
Status last verified
Feb 2016
First submitted
8 Feb 2016
Last updated
15 Feb 2016
Results posted
No

Publications

  • Roviello G, Milani M, Gobbi A, Dester M, Cappelletti MR, Allevi G, Aguggini S, Ravelli A, Gussago F, Cocconi A, Zanotti L, Senti C, Strina C, Bottini A, Generali D. A Phase II study of olaparib in breast cancer patients: biological evaluation from a 'window of opportunity' trial. Future Oncol. 2016 Oct;12(19):2189-93. doi: 10.2217/fon-2016-0116. Epub 2016 Jun 21.

    PubMed 27324108

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing olaparib in people with Breast Cancer and Triple Negative Breast Cancer, run by Istituti Ospitalieri di Cremona.

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 14 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 15 Feb 2016. 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 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?

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?

Correlation between baseline gene and protein expression profile and clinical response (time frame: Duration of the study). 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 NCT02681562, 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 15 Feb 2016.

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