REBECCA Real-world Early BrEast CanCer mAnagement REBECCA. a French National Multicentric Real-world Study of Early Breast Cancer Patients

REBECCA: Real-world study of early breast cancer treatment with olaparib in France

NCT: NCT06856343 · Status: RECRUITING · Phase: N/A · Sponsor: AstraZeneca · Started: 2024-12-30 · Est. Completion: 2028-01-31

Plain English Summary

REBECCA Real-world Early BrEast CanCer mAnagement is a Not Applicable clinical trial sponsored by AstraZeneca studying Breast Cancer. This study observes how well olaparib works for early HER2-negative breast cancer in a real-world setting. It is for adult patients in France diagnosed with HER2-negative early breast cancer. Participation involves agreeing to be observed while taking olaparib as prescribed by your doctor. There are no alternative treatments offered within this study; it observes standard care. The trial aims to enroll 126 participants.

Official Summary

This is a French observational, national, multicenter prospective cohort study of patients with HER2-negative eBC treated with olaparib at their physician's discretion.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults aged 18 and older diagnosed with HER2-negative early breast cancer. Patients starting olaparib treatment for their breast cancer, as decided by their doctor. Individuals who understand and agree to participate in the study. Patients who are not part of an Early Access Program for olaparib. This trial is studying Breast Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The main goal is to see what percentage of patients are able to complete their full course of olaparib treatment over 18 months, indicating how well the drug is tolerated and managed in routine care. The specific primary outcome measures are: Proportion of patients who receive Olaparib for the full treatment duration (18 months after inclusion). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial matters because it will provide valuable insights into how olaparib performs in everyday clinical practice for early breast cancer, helping to fill a gap in understanding its effectiveness This research targets Breast Cancer, where improved treatment options are needed.

Investor Insight

This observational study, sponsored by AstraZeneca, focuses on a specific treatment for early breast cancer, suggesting a market interest in understanding olaparib's real-world application and potenti

Is This Trial Right for Me?

Ask your doctor if olaparib is the right treatment for your specific type of breast cancer and if this study is a good fit for you. Understand that this is an observational study, meaning your treatment decisions are made by your doctor, and you will be followed to see how you do. Be prepared for regular medical appointments and follow-up as determined by your healthcare provider. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

* Male or female aged ≥ 18 years
* Patient diagnosed with HER2-negative eBC
* Patient about to be initiated with adjuvant Olaparib at their physician's discretion
* Patient has been informed and does not object to participation in the study.

Exclusion Criteria:

* Patient not consenting to participate.
* Patients included in the Early Access Program

Trial Locations

Frequently Asked Questions

What is clinical trial NCT06856343?

NCT06856343 is a Not Applicable OBSERVATIONAL study titled "REBECCA Real-world Early BrEast CanCer mAnagement." It is currently recruiting and is sponsored by AstraZeneca. The trial targets enrollment of 126 participants.

What conditions does NCT06856343 study?

This trial investigates treatments for Breast Cancer. The primary condition under study is Breast Cancer.

What does Not Applicable mean for NCT06856343?

This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.

What is the current status of NCT06856343?

This trial is currently "Recruiting." It started on 2024-12-30. The estimated completion date is 2028-01-31.

Who is sponsoring NCT06856343?

NCT06856343 is sponsored by AstraZeneca. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT06856343?

The trial aims to enroll 126 participants. The trial is currently recruiting and accepting new participants.

How is NCT06856343 designed?

This is a observational study.

What are the primary outcomes being measured in NCT06856343?

The primary outcome measures are: Proportion of patients who receive Olaparib for the full treatment duration (18 months after inclusion). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT06856343 being conducted?

This trial is being conducted at 20 sites, including Clermont-Ferrand, Auvergne-Rh ne-Alpes; Gleizé, Auvergne-Rh ne-Alpes; Grenoble, Auvergne-Rh ne-Alpes; Lyon, Auvergne-Rh ne-Alpes and 16 more sites (France).

Where can I find official information about NCT06856343?

The official record for NCT06856343 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06856343. This government database provides the most up-to-date and detailed information about the trial.

What is NCT06856343 testing in simple terms?

This study observes how well olaparib works for early HER2-negative breast cancer in a real-world setting. It is for adult patients in France diagnosed with HER2-negative early breast cancer.

Why is this trial significant?

This trial matters because it will provide valuable insights into how olaparib performs in everyday clinical practice for early breast cancer, helping to fill a gap in understanding its effectiveness

What are the potential risks of participating in NCT06856343?

The primary risk is experiencing side effects from olaparib, which can include nausea, fatigue, and changes in blood cell counts. Some patients may not be able to complete the full treatment duration due to side effects or other reasons. As this is an observational study, the risks are primarily associated with the prescribed treatment (olaparib) rather than the study itself. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT06856343?

Ask your doctor if olaparib is the right treatment for your specific type of breast cancer and if this study is a good fit for you. Understand that this is an observational study, meaning your treatment decisions are made by your doctor, and you will be followed to see how you do. Be prepared for regular medical appointments and follow-up as determined by your healthcare provider. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT06856343 signal from an investment perspective?

This observational study, sponsored by AstraZeneca, focuses on a specific treatment for early breast cancer, suggesting a market interest in understanding olaparib's real-world application and potenti This is a Not Applicable trial, which is in early development stages.

What happens if the treatment in this trial doesn't work?

Participation involves agreeing to be observed while taking olaparib as prescribed by your doctor. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.