Choice And Real Experience of Therapeutic deEscalation in Women Over 65 Year With Breast Cancer (CARTE)
Trial explores patient choice in breast cancer treatment reduction for women over 65
Plain English Summary
Patient's Choice in the Reduction of Their Treatment in Women Over 65 Year With Breast Cancer is a Not Applicable clinical trial sponsored by UNICANCER studying Breast Cancer. This trial tests three options for reducing radiation treatment after surgery for early breast cancer in women over 65. It is for women aged 65 and older diagnosed with early-stage, hormone-receptor-positive, HER2-negative breast cancer. Participation involves discussing treatment options with doctors and completing questionnaires about your choices and experiences. Alternatives include standard radiation therapy, a single dose of radiation during surgery, or no radiation at all. The trial aims to enroll 104 participants.
Official Summary
Standard treatment for women with early breast cancer (HR+, HER2-, T1N0) consists of the removal of the tumor from the breast by surgery with or without chemotherapy, followed by a whole-breast radiation therapy (usually one radiation treatment a day, five days a week, for 3 to 6 weeks) In some cases, for elderly patients older than 65 years with other associated pathologies, therapeutic de-escalation might be proposed in order to reduce the radiation doses received. Two options can be considered: * Intraoperative radiotherapy: radiation is delivered in a single dose directly to the tumor bed during the surgery. * Radiotherapy omission These three treatment options (whole-breast radiation therapy, Intraoperative radiotherapy or -Radiotherapy omission) have advantages and disadvantages. Intraoperative radiotherapy allows a targeted treatment and avoids several weeks of daily radiation. Radiotherapy omission prevents acute or late toxicities of the radiotherapy, as well as the constraints of daily travel over a period of 3 to 6 weeks. The aim of this trial is to offer patients aged 65 and over with early breast cancer, after surgery, these three treatment options and to study the choice and experience of treatment by patients. This study will assess the reasons that prompted patients to choose one of the three treatment options, the impact of medical and personal characteristics on this choice and the experience of therapeutic de-escalation as well as its effects, in particular on the course of care. This assessment will be carried out with self-administered questionnaires before and after the choice of treatment. In addition, to standardize the information given to patients in order to support them in their treatment choice and promote patient involvement in treatment decision-making, an encounter decision aid will be available for the patients. This encounter will detail the advantages and disadvantages of the three treatment options and will help in discussio
Who Can Participate
Here is what you need to know about eligibility for this trial. Women aged 65 or older with early-stage breast cancer. Must have a specific type of tumor (HR+, HER2-, T1N0) that is not lobular and has limited spread within the breast. Must be eligible for surgery and radiation therapy (either standard or during surgery). Cannot have recurrent or inflammatory breast cancer, or conditions that prevent radiation. This trial is studying Breast Cancer, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures how patients choose between different radiation therapy options, meaning it helps understand what factors influence a patient's decision when treatment can be less intense The specific primary outcome measures are: Patient's choice when de-escalation is proposed between whole breast radiotherapy (WBRT), Intra Operative Radiotherapy (IORT) or no radiotherapy (RT). (At baseline). 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 aims to personalize breast cancer treatment for older women by offering them choices that reduce treatment intensity while maintaining effectiveness, addressing a gap in This research targets Breast Cancer, where improved treatment options are needed.
Investor Insight
This trial focuses on a specific niche within breast cancer treatment for older adults, suggesting a growing market for personalized and less toxic therapies in oncology, with potential for improved p
Is This Trial Right for Me?
Ask your doctor about the pros and cons of each of the three treatment options (standard radiation, radiation during surgery, or no radiation). Be prepared to answer questionnaires before and after you make your treatment decision. The trial aims to support your decision-making process with a special tool that details the advantages and disadvantages of each option. The trial is being conducted at 1 site. 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
- Study Type: INTERVENTIONAL
- Allocation: NON_RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 104 participants
Interventions
- RADIATION: Whole breast radiotherapy — Whole breast radiotherapy after surgery
- RADIATION: Intra Operative Radiotherapy — Intra Operative Radiotherapy
Primary Outcomes
- Patient's choice when de-escalation is proposed between whole breast radiotherapy (WBRT), Intra Operative Radiotherapy (IORT) or no radiotherapy (RT). (At baseline)
Secondary Outcomes
- Final treatment received (WBRT, IORT or no RT) (6 weeks maximum (two weeks after surgery))
- Reason for the therapeutic choice from the patient's point of view (6 weeks maximum (two weeks after surgery))
- Encounter decision aid (EDA) rate of use (At baseline)
- Geriatric Core Dataset (G-CODE) (At baseline)
- Single Item Literacy Screener (SILS) (At baseline)
Full Eligibility Criteria
Inclusion Criteria: 1. Patient must have signed a written informed consent form prior to any study specific procedures; when the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor can confirm in writing the patient's consent 2. Women ≥65 years of age 3. Eastern Cooperative Oncology Group (ECOG) performance status ≤2 4. Clinical stage I, newly diagnosed breast cancer; invasive unifocal HR+ HER2- T1N0 tumour, not lobular, without extensive intraductal component (EIC) (\<25% EIC on biopsy), without embolism on biopsy 5. Eligible to surgery 6. Eligible for both WBRT or IORT 7. Chemotherapy treatment is possible if needed 8. Able to respond to self-report questionnaires in French 9. Affiliated to Social security System Exclusion Criteria: 1. Patient with recurrent breast cancer or inflammatory breast carcinoma 2. Absolute contra-indication to whole-breast irradiation as determined by the referring physician 3. Patient unable to comply with study obligations for geographic, social, or physical reasons, or who is unable to understand the purpose and procedures of the study 4. Patient enrolled in another therapeutic trial. Observational cohorts are accepted if the collection of data does not interfere with the current trial 5. Person deprived of their liberty or under protective custody or guardianship.
Trial Locations
- Institut Paoli-Calmettes, Marseille, France
Frequently Asked Questions
What is clinical trial NCT05058196?
NCT05058196 is a Not Applicable INTERVENTIONAL study titled "Patient's Choice in the Reduction of Their Treatment in Women Over 65 Year With Breast Cancer." It is currently completed and is sponsored by UNICANCER. The trial targets enrollment of 104 participants.
What conditions does NCT05058196 study?
This trial investigates treatments for Breast Cancer. The primary condition under study is Breast Cancer.
What treatments are being tested in NCT05058196?
The interventions being studied include: Whole breast radiotherapy (RADIATION), Intra Operative Radiotherapy (RADIATION). Whole breast radiotherapy after surgery
What does Not Applicable mean for NCT05058196?
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 NCT05058196?
This trial is currently "Completed." It started on 2021-10-01. The estimated completion date is 2025-10-15.
Who is sponsoring NCT05058196?
NCT05058196 is sponsored by UNICANCER. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT05058196?
The trial aims to enroll 104 participants. The trial status is completed.
How is NCT05058196 designed?
This is a interventional study, uses non_randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT05058196?
The primary outcome measures are: Patient's choice when de-escalation is proposed between whole breast radiotherapy (WBRT), Intra Operative Radiotherapy (IORT) or no radiotherapy (RT). (At baseline). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT05058196 being conducted?
This trial is being conducted at 1 site, including Marseille (France).
Where can I find official information about NCT05058196?
The official record for NCT05058196 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05058196. This government database provides the most up-to-date and detailed information about the trial.
What is NCT05058196 testing in simple terms?
This trial tests three options for reducing radiation treatment after surgery for early breast cancer in women over 65. It is for women aged 65 and older diagnosed with early-stage, hormone-receptor-positive, HER2-negative breast cancer.
Why is this trial significant?
This trial matters because it aims to personalize breast cancer treatment for older women by offering them choices that reduce treatment intensity while maintaining effectiveness, addressing a gap in
What are the potential risks of participating in NCT05058196?
Potential side effects of radiation therapy, such as skin irritation or fatigue, though these may be reduced with less intensive options. The risk that the chosen treatment may not be as effective as standard treatment, although the trial aims to balance effectiveness with reduced toxicity. The possibility of experiencing emotional or psychological impact related to treatment decisions and their outcomes. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT05058196?
Ask your doctor about the pros and cons of each of the three treatment options (standard radiation, radiation during surgery, or no radiation). Be prepared to answer questionnaires before and after you make your treatment decision. The trial aims to support your decision-making process with a special tool that details the advantages and disadvantages of each option. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT05058196 signal from an investment perspective?
This trial focuses on a specific niche within breast cancer treatment for older adults, suggesting a growing market for personalized and less toxic therapies in oncology, with potential for improved p 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 discussing treatment options with doctors and completing questionnaires about your choices and experiences. 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.