Breast CancerNCT03261323
Breast Reconstruction Following Breast Cancer in Very High Risk Patients
A study testing Immediate Breast Reconstruction, Delayed Breast Reconstruction and Breast-Q questionnaire in people with Breast Cancer and Malignant Neoplasm of Breast, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to: 1. Evaluate whether immediate or delayed reconstruction should be offered for breast reconstruction candidates with higher risk for surgical complications by comparing complications, quality of life, and hospital costs 2. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Breast Cancer, Malignant Neoplasm of Breast
- What is being tested?
- Immediate Breast Reconstruction, Delayed Breast Reconstruction and Breast-Q questionnaire
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2019to Jul 2022
- Phase
- Interventional
- 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 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have histologically or cytologically confirmed breast cancer or indication for prophylactic mastectomy.
- Subjects must be breast reconstruction candidates using implant based breast reconstruction.
- Subjects must have a pre-operative risk >20% complication prediction from the Breast Reconstruction Risk Assessment (BRA) Score for implant-based breast reconstruction candidates
- Subjects must have the ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Prior breast cancer surgical treatment
- Prior breast reconstruction
- Inability to provide written consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
About this study
Official title: Evaluating Breast Reconstruction Timing and Risk Reduction Strategies in Patients at a Higher Risk for Developing Breast Reconstruction Surgical Complications: A Prospective Randomized Study
The purpose of this study is to:
- Evaluate whether immediate or delayed reconstruction should be offered for breast reconstruction candidates with higher risk for surgical complications by comparing complications, quality of life, and hospital costs
- Determine the efficacy of risk reduction strategies for breast reconstruction patients with higher risk for surgical complications
Read the detailed description
Primary Endpoint(s)
- Define the optimal timing of reconstruction in patients at a higher risk for developing breast reconstruction surgical complications through a randomized prospective cohort
- Compare immediate and delayed reconstruction outcome metrics through retrospective review
Secondary Endpoint(s)
- Evaluate Quality of life of patients at a higher risk for developing breast reconstruction surgical complications undergoing immediate versus delayed reconstruction.
- Compare complications and reoperations between immediate versus delayed reconstruction.
- Compare the hospital costs between immediate versus delayed reconstruction
- Evaluate the effectiveness of risk reduction strategies
- Conditions
- Breast Cancer, Malignant Neoplasm of Breast
- Being tested
- Immediate Breast Reconstruction, Delayed Breast Reconstruction, Breast-Q questionnaire
- Keywords
- Breast Reconstruction, Mastectomy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate Breast ReconstructionProcedure or surgery
Only implant based surgeries will be considered in this study. The patient will be followed for at least 1 year after the last reconstruction surgery. Reconstruction will be attempted immediately after mastectomy.
Delayed Breast ReconstructionProcedure or surgery
Risk reduction strategies on smoking, weight, and chronic disease control will be offered. The individual risk will be recalculated every three months. Delayed breast reconstruction will be offered when core cancer therapies (mastectomy, chemotherapy and radiation) are complete. Only implant based surgeries will be considered in this study. The patient will be followed for at least 1 year after the last reconstruction surgery.
Breast-Q questionnaireOther
Developed out of Memorial Sloan-Kettering Institute for Cancer Research, this questionnaire is designed to create a patient-reported outcome measure to provide quantifiable information about the impact and effectiveness of breast surgery. In this study it will be used for quality of life assessment
| Study group | Role | What they receive |
|---|---|---|
| Immediate breast reconstruction | Active comparator | The surgical schedule will follow unaltered standard protocol for immediate reconstruction right after the patient's mastectomy. Patients will complete a quality of life questionnaire (Breast-Q) both pre-operatively and at different time points during the follow up. The patient's chart will be followed from the mastectomy surgery onwards until 1 year post-final reconstructive surgery for determining complications and hospital costs. Receives: Procedure: Immediate Breast Reconstruction; Other: Breast-Q questionnaire |
| Delayed breast reconstruction | Experimental | Patients will start the reconstruction process after cancer therapy has been completed. Patients will be directed to smoking cessation and weight loss resources such as the Bariatric Institute to most directly facilitate risk reduction goals. Risk scores will be assessed at a plastic surgery appointment every 3 months. Reconstruction will proceed after the cancer treatment has been completed, according to individual patient evaluation. Patients will complete a quality of life questionnaire (Breast-Q) both pre-operatively and after the final reconstruction surgery. The patient's chart will be followed from the mastectomy surgery onwards until 1 year post-final reconstructive surgery for determining complications and hospital costs. Receives: Procedure: Delayed Breast Reconstruction; Other: Breast-Q questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
optimal timing of reconstruction in patients at a higher risk for developing breast reconstruction surgical complications
Proportion of patients preferring delayed reconstruction.
Measured: Until 1 year post breast reconstruction
Secondary outcomes (5)
Major complications
defined as the ones that required reoperation (infection, capsular contracture, hematoma, seroma, skin flap and flap necrosis, etc).
Measured: Until 1 year post breast reconstruction
Minor complications
defined as the ones that were office treated, not requiring a reoperation
Measured: Until 1 year post breast reconstruction
Number of revision surgeries
defined as surgeries not related to complications, indicated for symmetrization, aesthetic improvement, nipple reconstruction, or skin paddle removal
Measured: Until 1 year post breast reconstruction
Hospital cost of the complete reconstruction treatment
Cost of reconstruction including the cost of complications
Measured: Until 1 year post breast reconstruction
Change in patient satisfaction
Patient satisfaction using the pre-operative Breast-Q questionnaire to define the baseline compared to score on Breast-Q questionnaire during follow-up
Measured: Until 1 year post breast reconstruction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start31 May 2019
- Primary completionJul 2022 (estimated)
- Study completionJul 2022 (estimated)
Why it stopped: insufficient staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Risal Djohan, MD, Principal investigator, Cleveland Clinic, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03261323
- Sponsor's protocol ID
- CASE10116
- Status last verified
- May 2022
- First submitted
- 19 Jul 2017
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Breast Reconstruction Timing and Risk Reduction Strategies in Patients at a Higher Risk for Developing Breast Reconstruction Surgical Complications: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT03261323
- Acronym / sponsor ID
- CASE10116
- Conditions
- Breast Cancer, Malignant Neoplasm of Breast
- Keywords
- Breast Reconstruction, Mastectomy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: insufficient staff
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 31 May 2019 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 25 Aug 2017 (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 purpose of this study is to:
- Evaluate whether immediate or delayed reconstruction should be offered for breast reconstruction candidates with higher risk for surgical complications by comparing complications, quality of life, and hospital costs
- Determine the efficacy of risk reduction strategies for breast reconstruction patients with higher risk for surgical complications
Detailed description
Primary Endpoint(s)
- Define the optimal timing of reconstruction in patients at a higher risk for developing breast reconstruction surgical complications through a randomized prospective cohort
- Compare immediate and delayed reconstruction outcome metrics through retrospective review
Secondary Endpoint(s)
- Evaluate Quality of life of patients at a higher risk for developing breast reconstruction surgical complications undergoing immediate versus delayed reconstruction.
- Compare complications and reoperations between immediate versus delayed reconstruction.
- Compare the hospital costs between immediate versus delayed reconstruction
- Evaluate the effectiveness of risk reduction strategies
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate breast reconstruction | Active comparator | Procedure: Immediate Breast Reconstruction, Other: Breast-Q questionnaireThe surgical schedule will follow unaltered standard protocol for immediate reconstruction right after the patient's mastectomy. Patients will complete a quality of life questionnaire (Breast-Q) both pre-operatively and at different time points during the follow up. The patient's chart will be followed from the mastectomy surgery onwards until 1 year post-final reconstructive surgery for determining complications and hospital costs. |
| Delayed breast reconstruction | Experimental | Procedure: Delayed Breast Reconstruction, Other: Breast-Q questionnairePatients will start the reconstruction process after cancer therapy has been completed. Patients will be directed to smoking cessation and weight loss resources such as the Bariatric Institute to most directly facilitate risk reduction goals. Risk scores will be assessed at a plastic surgery appointment every 3 months. Reconstruction will proceed after the cancer treatment has been completed, according to individual patient evaluation. Patients will complete a quality of life questionnaire (Breast-Q) both pre-operatively and after the final reconstruction surgery. The patient's chart will be followed from the mastectomy surgery onwards until 1 year post-final reconstructive surgery for determining complications and hospital costs. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects must have histologically or cytologically confirmed breast cancer or indication for prophylactic mastectomy.
- Subjects must be breast reconstruction candidates using implant based breast reconstruction.
- Subjects must have a pre-operative risk >20% complication prediction from the Breast Reconstruction Risk Assessment (BRA) Score for implant-based breast reconstruction candidates
- Subjects must have the ability to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (3 listed)
- Prior breast cancer surgical treatment
- Prior breast reconstruction
- Inability to provide written consent
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 |
|---|---|---|
| Immediate Breast ReconstructionOnly implant based surgeries will be considered in this study. The patient will be followed for at least 1 year after the last reconstruction surgery. Reconstruction will be attempted immediately after mastectomy. | Procedure or surgery | Immediate breast reconstruction |
| Delayed Breast ReconstructionRisk reduction strategies on smoking, weight, and chronic disease control will be offered. The individual risk will be recalculated every three months. Delayed breast reconstruction will be offered when core cancer therapies (mastectomy, chemotherapy and radiation) are complete. Only implant based surgeries will be considered in this study. The patient will be followed for at least 1 year after the last reconstruction surgery. | Procedure or surgery | Delayed breast reconstruction |
| Breast-Q questionnaireDeveloped out of Memorial Sloan-Kettering Institute for Cancer Research, this questionnaire is designed to create a patient-reported outcome measure to provide quantifiable information about the impact and effectiveness of breast surgery. In this study it will be used for quality of life assessment | Other | Delayed breast reconstruction, Immediate breast reconstruction |
Primary outcome
optimal timing of reconstruction in patients at a higher risk for developing breast reconstruction surgical complications
Time frame: Until 1 year post breast reconstruction
Proportion of patients preferring delayed reconstruction.
5 secondary outcomes
Major complications
Time frame: Until 1 year post breast reconstruction
Minor complications
Time frame: Until 1 year post breast reconstruction
Number of revision surgeries
Time frame: Until 1 year post breast reconstruction
Hospital cost of the complete reconstruction treatment
Time frame: Until 1 year post breast reconstruction
Change in patient satisfaction
Time frame: Until 1 year post breast reconstruction
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
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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.
Risal Djohan, MD principal investigator
Cleveland Clinic, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate Breast Reconstruction, Delayed Breast Reconstruction and Breast-Q questionnaire in people with Breast Cancer and Malignant Neoplasm of Breast, run by Case Comprehensive Cancer Center at 1 site in United States.
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 4 inclusion and 3 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: withdrawn, as of the sponsor's last update on 20 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
optimal timing of reconstruction in patients at a higher risk for developing breast reconstruction surgical complications (time frame: Until 1 year post breast reconstruction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2022; AzTrials last refreshed its copy on 8 Nov 2026.