Evaluating outcomes of breast-conserving surgery for cancer patients
Oncologic, Cosmetic and Patient Reported Outcomes in Value-Based Breast Surgery. A Multicentre, Cohort Study
Uppsala University · NCT06401304
This study is testing how well a specific type of breast surgery works for cancer patients and how it affects their quality of life and recovery, while also considering their personal choices in treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1200 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Uppsala University (other) |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 3 sites (Sydney and 2 other locations) |
| Trial ID | NCT06401304 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the outcomes of oncoplastic breast-conserving surgery (OPBCS) in patients with pre-invasive or invasive breast cancer. It focuses on developing and validating a standardized surgical assessment tool within a shared decision-making framework. The study will gather data on surgical outcomes, quality of life, and time-to-event outcomes, addressing the individualized nature of surgical decision-making in breast cancer treatment. By analyzing various factors such as tumor location and patient preferences, the study seeks to improve the standardization of surgical techniques.
Who should consider this trial
Good fit: Ideal candidates include females over 18 years old with invasive breast cancer or ductal carcinoma in situ who are eligible for breast-conserving surgery.
Not a fit: Patients with a life expectancy of less than 6 months or those who are not candidates for breast conservation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance surgical decision-making and improve quality of life for breast cancer patients undergoing conservation surgery.
How similar studies have performed: While there is limited randomized controlled trial data on this specific approach, similar studies have shown promising outcomes in the field of breast-conserving surgery.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Female aged above 18 years. 2. Signed and dated written informed consent before the start of specific protocol procedures; oral consent for the participants of the quality control retrospective cohort study before accepting to partake a telephone interview. 3. Patients with invasive breast cancer (IBC) or ductal cancer in situ (DCIS) or unclear lesions mandating surgical excision or benign lesions amenable for surgical resection with BCS. 4. ECOG performance status 0-2. Exclusion Criteria 1. Life expectancy of less than 6 months 2. Non candidate for breast conservation 3. Inability to understand given information and give informed consent or undergo study procedures
Where this trial is running
Sydney and 2 other locations
- Westmead Breast Cancer Institute — Sydney, Australia (RECRUITING)
- Uppsala University Hospital — Uppsala, Sweden (RECRUITING)
- Royal Marsden Hospital — London, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Andreas Karakatsanis, MD, PhD — Uppsala University
- Study coordinator: Andreas U Karakatsanis, MD, PhD
- Email: andreas.karakatsanis@uu.se
- Phone: +46765864826
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, Breast Carcinoma in Situ, Breast Cancer Invasive, Breast Asymmetry, Oncoplastic breast conservation, Breast Conserving Surgery, Patient reported outcomes, Shared decision making