Breast Cancer Stage INCT05724758
Patient Reported Outcomes After Oncoplastic Breast Conserving Surgery
An observational study of Breast Cancer Stage I and Breast Cancer Stage II, run by Brust-Zentrum AG.
Trial summary
The goal of this study is to assess patient satisfaction after oncoplastic breast conserving surgery. With the help of a breast-questionnaire the patient satisfaction will be assessed before the surgery and 4 weeks, 6 months and 1 year after the operation. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer in Situ
- What is being tested?
- Breast-conserving surgery
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2023to 1 Sep 2024
- Phase
- Observational
- 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
Study population: Patients from Brust-Zentrum Zürich undergoing oncoplastic breast surgery recruited between March and September 2023
Who may be able to join
- BCT oncoplastic surgery technique
- Women > 18 years
Who cannot join
- Previously treated ipsilateral breast cancer or DCIS
- Severe psychological illness by doctors' discretion (as taking part in a study could increase anxiety) or severe dementia, that stops them to consent to the procedure
- Pregnant women
- Distant metastatic disease (M1)
Trial locations and contacts
No sites are listed yet.
About this study
The goal of this study is to assess patient satisfaction after oncoplastic breast conserving surgery. With the help of a breast-questionnaire the patient satisfaction will be assessed before the surgery and 4 weeks, 6 months and 1 year after the operation. The main question it aims to answer are: Does breast conserving surgery improve quality of life.
type of study: cohort study, observational
Read more
OCBS = oncoplastic breast conserving surgery BCT = breast conserving therapy DCIS = ductal carcinoma in situ
participant population/health conditions
- Patients with newly diagnosed breast cancer, that can be treated breast conserving
- the participants have to be at least 18 years old
Participants will fill out a questionnaire pre surgery, 4 weeks, 6 months and 1 year after the surgery. The individual questionnaires will be compared.
Read the detailed description
The management of breast cancer has undergone a significant shift over the last century. The advances in systemic therapy have not only improved the overall prognosis however also allowed for less radical surgery and more breast conservable efforts. The term oncoplastic breast conserving surgery was first coined in the early 90s where breast cancer surgery was performed while incorporating plastic surgical techniques. Therefore, this enabled the preservation of the natural breast shape with good aesthetic outcomes. Over the years oncoplastic breast conserving surgery has become widely accepted and adopted into routine clinical practice by most breast cancer surgeons. The oncological safety surrounding oncoplastic breast conserving surgery have been well established. Rates of positive surgical margins and re-excision rates have been shown to be similar to traditional lumpectomy operations. Complication rates are also comparable and oncoplastic breast conserving surgery does not result in delays in adjuvant treatments. However, many surgeons would concur that the most significant benefit of oncoplastic breast conserving surgery (OBCS) is patient satisfaction and the potential improvement in their quality of life.
Patient reported outcomes (PROMs) allow us to objectively assess patient satisfaction and the impact the intervention has had onto their lives. Incorporating PROMs into daily clinical practice would not only facilitate shared-decision making but also allow us to tailor clinical management to suit individual patient needs. This study however also aims to assess the patient reported outcome after breast surgery and in the follow up time (after radiotherapy, ...).
- Being tested
- Breast-conserving surgery
- Medical subject headings
- Breast Neoplasms, Breast Carcinoma In Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast-conserving surgeryProcedure or surgery
Following oncoplastic surgeries are performed at the Brust-Zentrum in Zurich:
- Oncoplastic reconstruction with round-block technique
- Oncoplastic reconstruction using J-Plastic
- Oncoplastic reconstruction using V-Plastic
- Oncoplastic reconstruction using Grisotti
- Oncoplastic reconstruction using Batwing
- Oncoplastic reconstruction using Mammareductionplasty (Wise Pattern, Vertical)
- Oncoplastic perforator flap surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of patient satisfaction with their breasts pre- and post breast-conserving surgery
To assess patient satisfaction using BREAST-Q over the duration of the breast cancer clinical management and follow up i.e., pre-, and postoperative: 4 weeks, 6 months and 1 year after the surgery.
Measured: before the surgery and 4 weeks after the surgery
Change of quality of Life pre- and post breast-conserving surgery
To assess Quality of Life using BREAST-Q over the duration of the breast cancer clinical management and follow up i.e., pre-, and postoperative: 4 weeks, 6 months and 1 year after the surgery.
Measured: before the surgery and 4 weeks after the surgery
Secondary outcomes (1)
impact of age (>70 and < 60 years old) on Patient reported outcome measures
To assess the impact of age (> 70 and < 60 years old) on patient reported outcome measures (validated questionnaire) after oncoplastic surgery, If age has an impact on patient satisfaction with their breasts pre and post surgery
Measured: baseline and 4 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start1 Mar 2023 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer Stage IStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brust-Zentrum AG
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05724758
- Sponsor's protocol ID
- Patient reported outcome
- Status last verified
- Jan 2023
- First submitted
- 4 Jan 2023
- Last updated
- 13 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Freites-Martinez A, Santana N, Arias-Santiago S, Viera A. Using the Common Terminology Criteria for Adverse Events (CTCAE - Version 5.0) to Evaluate the Severity of Adverse Events of Anticancer Therapies. Actas Dermosifiliogr (Engl Ed). 2021 Jan;112(1):90-92. doi: 10.1016/j.ad.2019.05.009. Epub 2020 Sep 3. No abstract available. English, Spanish.
PubMed 32891586World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.
PubMed 24141714Weigelt E, Scherb H. [Data protection and data access (I): federal data protection law and the social welfare code with reference to carrying out occupational medicine epidemiologic studies in Germany]. Gesundheitswesen. 1992 Nov;54(11):666-72. German.
PubMed 1286250McIntosh J, O'Donoghue JM. Therapeutic mammaplasty--a systematic review of the evidence. Eur J Surg Oncol. 2012 Mar;38(3):196-202. doi: 10.1016/j.ejso.2011.12.004. Epub 2011 Dec 27.
PubMed 22206704Carter SA, Lyons GR, Kuerer HM, Bassett RL Jr, Oates S, Thompson A, Caudle AS, Mittendorf EA, Bedrosian I, Lucci A, DeSnyder SM, Babiera G, Yi M, Baumann DP, Clemens MW, Garvey PB, Hunt KK, Hwang RF. Operative and Oncologic Outcomes in 9861 Patients with Operable Breast Cancer: Single-Institution Analysis of Breast Conservation with Oncoplastic Reconstruction. Ann Surg Oncol. 2016 Oct;23(10):3190-8. doi: 10.1245/s10434-016-5407-9. Epub 2016 Jul 12.
PubMed 27406093Rose M, Manjer J, Ringberg A, Svensson H. Surgical strategy, methods of reconstruction, surgical margins and postoperative complications in oncoplastic breast surgery. Eur J Plast Surg. 2014;37(4):205-214. doi: 10.1007/s00238-013-0922-4. Epub 2014 Feb 1.
PubMed 24659858Kaviani A, Sodagari N, Sheikhbahaei S, Eslami V, Hafezi-Nejad N, Safavi A, Noparast M, Fitoussi A. From radical mastectomy to breast-conserving therapy and oncoplastic breast surgery: a narrative review comparing oncological result, cosmetic outcome, quality of life, and health economy. ISRN Oncol. 2013 Sep 12;2013:742462. doi: 10.1155/2013/742462.
PubMed 24167743Wijgman DJ, Ten Wolde B, van Groesen NR, Keemers-Gels ME, van den Wildenberg FJ, Strobbe LJ. Short term safety of oncoplastic breast conserving surgery for larger tumors. Eur J Surg Oncol. 2017 Apr;43(4):665-671. doi: 10.1016/j.ejso.2016.11.021. Epub 2016 Dec 18.
PubMed 28041648Nizet JL, Maweja S, Lakosi F, Lifrange E, Scagnol I, Seidel L, Albert A, Jerusalem G. Oncological and surgical outcome after oncoplastic breast surgery. Acta Chir Belg. 2015 Jan-Feb;115:33-41.
PubMed 26021789Cil TD, Cordeiro E. Complications of Oncoplastic Breast Surgery Involving Soft Tissue Transfer Versus Breast-Conserving Surgery: An Analysis of the NSQIP Database. Ann Surg Oncol. 2016 Oct;23(10):3266-71. doi: 10.1245/s10434-016-5477-8. Epub 2016 Aug 12.
PubMed 27518043Klit A, Tvedskov TF, Kroman N, Elberg JJ, Ejlertsen B, Henriksen TF. Oncoplastic breast surgery does not delay the onset of adjuvant chemotherapy: a population-based study. Acta Oncol. 2017 May;56(5):719-723. doi: 10.1080/0284186X.2017.1281437. Epub 2017 Feb 6.
PubMed 28162018Rose M, Svensson H, Handler J, Hoyer U, Ringberg A, Manjer J. Patient-reported outcome after oncoplastic breast surgery compared with conventional breast-conserving surgery in breast cancer. Breast Cancer Res Treat. 2020 Feb;180(1):247-256. doi: 10.1007/s10549-020-05544-2. Epub 2020 Jan 27.
PubMed 31989380Pusic AL, Klassen AF, Scott AM, Klok JA, Cordeiro PG, Cano SJ. Development of a new patient-reported outcome measure for breast surgery: the BREAST-Q. Plast Reconstr Surg. 2009 Aug;124(2):345-353. doi: 10.1097/PRS.0b013e3181aee807.
PubMed 19644246Stolpner I, Heil J, Feisst M, Karsten MM, Weber WP, Blohmer JU, Forster T, Golatta M, Schutz F, Sohn C, Hennigs A. Clinical Validation of the BREAST-Q Breast-Conserving Therapy Module. Ann Surg Oncol. 2019 Sep;26(9):2759-2767. doi: 10.1245/s10434-019-07456-y. Epub 2019 May 21.
PubMed 31115853Cordova LZ, Hunter-Smith DJ, Rozen WM. Patient reported outcome measures (PROMs) following mastectomy with breast reconstruction or without reconstruction: a systematic review. Gland Surg. 2019 Aug;8(4):441-451. doi: 10.21037/gs.2019.07.02.
PubMed 31538070
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Reported Outcomes After Oncoplastic Breast Conserving Surgery
- ClinicalTrials.gov ID
- NCT05724758
- Acronym / sponsor ID
- Patient reported outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Brust-Zentrum AGUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 13 Feb 2023 (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.
The goal of this study is to assess patient satisfaction after oncoplastic breast conserving surgery. With the help of a breast-questionnaire the patient satisfaction will be assessed before the surgery and 4 weeks, 6 months and 1 year after the operation. The main question it aims to answer are: Does breast conserving surgery improve quality of life.
type of study: cohort study, observational
OCBS = oncoplastic breast conserving surgery BCT = breast conserving therapy DCIS = ductal carcinoma in situ
participant population/health conditions
- Patients with newly diagnosed breast cancer, that can be treated breast conserving
- the participants have to be at least 18 years old
Participants will fill out a questionnaire pre surgery, 4 weeks, 6 months and 1 year after the surgery. The individual questionnaires will be compared.
Detailed description
The management of breast cancer has undergone a significant shift over the last century. The advances in systemic therapy have not only improved the overall prognosis however also allowed for less radical surgery and more breast conservable efforts. The term oncoplastic breast conserving surgery was first coined in the early 90s where breast cancer surgery was performed while incorporating plastic surgical techniques. Therefore, this enabled the preservation of the natural breast shape with good aesthetic outcomes. Over the years oncoplastic breast conserving surgery has become widely accepted and adopted into routine clinical practice by most breast cancer surgeons. The oncological safety surrounding oncoplastic breast conserving surgery have been well established. Rates of positive surgical margins and re-excision rates have been shown to be similar to traditional lumpectomy operations. Complication rates are also comparable and oncoplastic breast conserving surgery does not result in delays in adjuvant treatments. However, many surgeons would concur that the most significant benefit of oncoplastic breast conserving surgery (OBCS) is patient satisfaction and the potential improvement in their quality of life.
Patient reported outcomes (PROMs) allow us to objectively assess patient satisfaction and the impact the intervention has had onto their lives. Incorporating PROMs into daily clinical practice would not only facilitate shared-decision making but also allow us to tailor clinical management to suit individual patient needs. This study however also aims to assess the patient reported outcome after breast surgery and in the follow up time (after radiotherapy, ...).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from Brust-Zentrum Zürich undergoing oncoplastic breast surgery recruited between March and September 2023
Key inclusion criteria (2 listed)
- BCT oncoplastic surgery technique
- Women > 18 years
Key exclusion criteria (4 listed)
- Previously treated ipsilateral breast cancer or DCIS
- Severe psychological illness by doctors' discretion (as taking part in a study could increase anxiety) or severe dementia, that stops them to consent to the procedure
- Pregnant women
- Distant metastatic disease (M1)
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 |
|---|---|---|
| Breast-conserving surgeryFollowing oncoplastic surgeries are performed at the Brust-Zentrum in Zurich: * Oncoplastic reconstruction with round-block technique * Oncoplastic reconstruction using J-Plastic * Oncoplastic reconstruction using V-Plastic * Oncoplastic reconstruction using Grisotti * Oncoplastic reconstruction using Batwing * Oncoplastic reconstruction using Mammareductionplasty (Wise Pattern, Vertical) * Oncoplastic perforator flap surgery | Procedure or surgery | – |
Primary outcome
Change of patient satisfaction with their breasts pre- and post breast-conserving surgery
Time frame: before the surgery and 4 weeks after the surgery
To assess patient satisfaction using BREAST-Q over the duration of the breast cancer clinical management and follow up i.e., pre-, and postoperative: 4 weeks, 6 months and 1 year after the surgery.
Change of quality of Life pre- and post breast-conserving surgery
Time frame: before the surgery and 4 weeks after the surgery
To assess Quality of Life using BREAST-Q over the duration of the breast cancer clinical management and follow up i.e., pre-, and postoperative: 4 weeks, 6 months and 1 year after the surgery.
1 secondary outcome
impact of age (>70 and < 60 years old) on Patient reported outcome measures
Time frame: baseline and 4 weeks postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Background: PubMed 32891586Freites-Martinez A, Santana N, Arias-Santiago S, Viera A. Using the Common Terminology Criteria for Adverse Events (CTCAE - Version 5.0) to Evaluate the Severity of Adverse Events of Anticancer Therapies. Actas Dermosifiliogr (Engl Ed). 2021 Jan;112(1):90-92. doi: 10.1016/j.ad.2019.05.009. Epub 2020 Sep 3. No abstract available. English, Spanish.
- Background: PubMed 24141714World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.
- Background: PubMed 1286250Weigelt E, Scherb H. [Data protection and data access (I): federal data protection law and the social welfare code with reference to carrying out occupational medicine epidemiologic studies in Germany]. Gesundheitswesen. 1992 Nov;54(11):666-72. German.
- Background: PubMed 22206704McIntosh J, O'Donoghue JM. Therapeutic mammaplasty--a systematic review of the evidence. Eur J Surg Oncol. 2012 Mar;38(3):196-202. doi: 10.1016/j.ejso.2011.12.004. Epub 2011 Dec 27.
- Background: PubMed 27406093Carter SA, Lyons GR, Kuerer HM, Bassett RL Jr, Oates S, Thompson A, Caudle AS, Mittendorf EA, Bedrosian I, Lucci A, DeSnyder SM, Babiera G, Yi M, Baumann DP, Clemens MW, Garvey PB, Hunt KK, Hwang RF. Operative and Oncologic Outcomes in 9861 Patients with Operable Breast Cancer: Single-Institution Analysis of Breast Conservation with Oncoplastic Reconstruction. Ann Surg Oncol. 2016 Oct;23(10):3190-8. doi: 10.1245/s10434-016-5407-9. Epub 2016 Jul 12.
- Background: PubMed 24659858Rose M, Manjer J, Ringberg A, Svensson H. Surgical strategy, methods of reconstruction, surgical margins and postoperative complications in oncoplastic breast surgery. Eur J Plast Surg. 2014;37(4):205-214. doi: 10.1007/s00238-013-0922-4. Epub 2014 Feb 1.
- Background: PubMed 24167743Kaviani A, Sodagari N, Sheikhbahaei S, Eslami V, Hafezi-Nejad N, Safavi A, Noparast M, Fitoussi A. From radical mastectomy to breast-conserving therapy and oncoplastic breast surgery: a narrative review comparing oncological result, cosmetic outcome, quality of life, and health economy. ISRN Oncol. 2013 Sep 12;2013:742462. doi: 10.1155/2013/742462.
- Background: PubMed 28041648Wijgman DJ, Ten Wolde B, van Groesen NR, Keemers-Gels ME, van den Wildenberg FJ, Strobbe LJ. Short term safety of oncoplastic breast conserving surgery for larger tumors. Eur J Surg Oncol. 2017 Apr;43(4):665-671. doi: 10.1016/j.ejso.2016.11.021. Epub 2016 Dec 18.
- Background: PubMed 26021789Nizet JL, Maweja S, Lakosi F, Lifrange E, Scagnol I, Seidel L, Albert A, Jerusalem G. Oncological and surgical outcome after oncoplastic breast surgery. Acta Chir Belg. 2015 Jan-Feb;115:33-41.
- Background: PubMed 27518043Cil TD, Cordeiro E. Complications of Oncoplastic Breast Surgery Involving Soft Tissue Transfer Versus Breast-Conserving Surgery: An Analysis of the NSQIP Database. Ann Surg Oncol. 2016 Oct;23(10):3266-71. doi: 10.1245/s10434-016-5477-8. Epub 2016 Aug 12.
- Background: PubMed 28162018Klit A, Tvedskov TF, Kroman N, Elberg JJ, Ejlertsen B, Henriksen TF. Oncoplastic breast surgery does not delay the onset of adjuvant chemotherapy: a population-based study. Acta Oncol. 2017 May;56(5):719-723. doi: 10.1080/0284186X.2017.1281437. Epub 2017 Feb 6.
- Background: PubMed 31989380Rose M, Svensson H, Handler J, Hoyer U, Ringberg A, Manjer J. Patient-reported outcome after oncoplastic breast surgery compared with conventional breast-conserving surgery in breast cancer. Breast Cancer Res Treat. 2020 Feb;180(1):247-256. doi: 10.1007/s10549-020-05544-2. Epub 2020 Jan 27.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Stage I and Breast Cancer Stage II, run by Brust-Zentrum AG.
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 2 inclusion and 4 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 13 Feb 2023. 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.
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?
Contact Kavitha Däster, Dr. med. (+41 44 533 81 00, kavitha.daester@brust-zentrum.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of patient satisfaction with their breasts pre- and post breast-conserving surgery (time frame: before the surgery and 4 weeks after the surgery). The study lists 2 primary outcomes in all. 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 NCT05724758, which also lists 17 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 13 Feb 2023.