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Trial record 1 of 1 for:    NCT04293146
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Pre- Versus Sub-pectoral Implant-based Breast Reconstruction After Skin-sparing Mastectomy or Nipple-sparing Mastectomy OPBC-02PREPEC (OPBC-02PREPEC)

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ClinicalTrials.gov Identifier: NCT04293146
Recruitment Status : Recruiting
First Posted : March 3, 2020
Last Update Posted : August 26, 2020
Sponsor:
Collaborator:
Swiss National Science Foundation
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:
This trial is to investigate whether pre-pectoral Implant-Based Breast Reconstruction (IBBR) provides better Quality of Life (QoL) with respect to long-term (24 months) physical well-being (chest) compared to sub-pectoral IBBR for patients undergoing skin-sparing mastectomy or nipple-sparing mastectomy for prevention or treatment of breast cancer.

Condition or disease Intervention/treatment Phase
Breast Reconstruction Implant-Based Breast Reconstruction (IBBR) Procedure: pre-pectoral IBBR Procedure: sub-pectoral IBBR Not Applicable

Detailed Description:
This trial is to investigate whether pre-pectoral Implant-Based Breast Reconstruction (IBBR) provides better Quality of Life (QoL) with respect to long-term (24 months) physical well-being (chest) compared to sub-pectoral IBBR for patients undergoing skin-sparing mastectomy or nipple-sparing mastectomy for prevention or treatment of breast cancer.The aim is to adhere to standard of care as much as possible to follow the pragmatic trial design to generate data that are applicable to today's practice. Therefore, surgeons are allowed to use their preferred Acellular Dermal Matrix (ADM), synthetic meshes, expanders and implants, thereby offering practitioners considerable leeway in deciding how to perform the procedure. For the same reason, both the one- and two-staged IBBR approaches are allowed when studying pre- versus sub-pectoral IBBR.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 372 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study will objectively assess the results and complication of two surgical techniques and thus provide evidence to assess whether there are differences between these techniques.
Masking: Single (Outcomes Assessor)
Masking Description: blinded outcome assessment for aesthetic results
Primary Purpose: Other
Official Title: Pre- Versus Sub-pectoral Implant-based Breast Reconstruction After Skin-sparing Mastectomy or Nipple-sparing Mastectomy (OPBC-02/ PREPEC): A Pragmatic, Multicenter, Randomized, Superiority Trial
Actual Study Start Date : July 28, 2020
Estimated Primary Completion Date : March 2032
Estimated Study Completion Date : March 2033

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: pre-pectoral IBBR Procedure: pre-pectoral IBBR
The breast is reconstructed by positioning a breast implant above (pre-pectoral) the pectoralis major muscle.

Active Comparator: sub-pectoral IBBR Procedure: sub-pectoral IBBR
The breast is reconstructed by positioning a breast implant below (sub-pectoral) the pectoralis major muscle.




Primary Outcome Measures :
  1. Change in BREAST-Q scale [ Time Frame: within 24 months after mastectomy (screening, day 10, and months 1, 6, 12 and 24) ]
    compare the Quality of Life (QoL) with respect to long-term physical well-being (chest) after pre-pectoral or sub-pectoral IBBR. The BREAST-Q module specific to breast reconstruction version 2.0 consists of 13 independent scales covering health-related QoL domains and satisfaction domains. Each scale is scored to generate a numerical score on a scale from 0 (worst) to 100 (best).

  2. Change in EQ-5D-5L questionnaire [ Time Frame: within 24 months after mastectomy (screening, day 10, and months 1, 6, 12 and 24) ]
    The 5-level version of the EQ-5D (EQ-5D-5L) consists of the EQ-5D descriptive system that comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/Depression (5 answer levels each: no problems, slight problems, moderate problems, severe problems and extreme problems), resulting in a 1-digit number that expresses the level for that dimension. The digits for each dimension are combined into a 5-digit number that describes the patient's health state and is subsequently converted into a preference-based quality of life weight (utility) using an algorithm derived from population-based studies. In addition, patients are asked to rate their health on a vertical visual analogue scale (EQ VAS), where the anchors are labelled with 'The best health you can imagine' and 'The worst health you can imagine'.


Secondary Outcome Measures :
  1. loss of expander or implant [ Time Frame: within 24 months of undergoing mastectomy and immediate reconstruction ]
    compare the safety of pre-pectoral and sub-pectoral IBBR, in terms of loss of expander or implant. Loss of expander or implant is defined as an unplanned surgical removal of expander/implant with or without immediate replacement.

  2. surgical complications [ Time Frame: within 24 months of undergoing mastectomy and immediate reconstruction ]
    compare the safety of pre-pectoral and sub-pectoral IBBR, in terms of surgical complications. The complications include: Wound dehiscence, Haematoma, Seroma, Implant/expander exposure/Extrusion, Implant/Expander rotation/malpositioning, Infection, Mastectomy skin flap necrosis, Capsular contraction, Lymphedema

  3. thromboembolic events [ Time Frame: within 24 months of undergoing mastectomy and immediate reconstruction ]
    compare the safety of pre-pectoral and sub-pectoral IBBR, in terms of thromboembolic events according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0

  4. patient satisfaction [ Time Frame: over 24 months since mastectomy ]
    compare patient satisfaction after pre-pectoral or sub-pectoral IBBR

  5. animation deformity [ Time Frame: before and 24 months after the mastectomy ]
    compare animation deformity after pre-pectoral or sub-pectoral IBBR by using pictures from before and 24 months after the mastectomy

  6. capsular contracture [ Time Frame: before and 24 months after the mastectomy ]
    compare capsular contracture after pre-pectoral or sub-pectoral IBBR by using pictures from before and 24 months after the mastectomy

  7. aesthetic results [ Time Frame: before and 24 months after the mastectomy ]
    compare aesthetic results after pre-pectoral or sub-pectoral IBBR assessed by photographs of the breast taken in a standardized way. They will be evaluated by an experienced investigator who is blinded for group assignment. The blinded outcome assessment team will be trained to enter data for the two most widely used semi-automatic software for objective aesthetic evaluation, the 'Breast Cancer Conservative Treatment cosmetic results' (BCCT.core)

  8. Recurrence-free survival (RFS) [ Time Frame: until 10 years after mastectomy and IBBR. ]
    RFS is defined as the time from randomization until the first documentation of any of the following events: local-regional occurrence or recurrence of invasive disease or ductal carcinoma in situ (DCIS), distant breast cancer metastasis, or death from any cause.

  9. aesthetic results evaluated by patients [ Time Frame: at baseline and after 24 months ]
    evaluated by patients using a four point scale: excellent, good, regular, bad.

  10. total number of operative procedures [ Time Frame: until 24 months after mastectomy ]
    assess the burden on patients by total number of operative procedures

  11. length of hospital stay (index hospitalization and overall) [ Time Frame: until 24 months after randomization ]
    length of hospital stay (index hospitalization and overall) following randomization until discharge and the cumulative number of days the patient was hospitalized

  12. total number of outpatient visits at the trial site and the emergency department [ Time Frame: from admission for mastectomy until 24 months after randomization ]
    assess the burden on patients by total number of outpatient visits at the trial site and the emergency department

  13. aesthetic results evaluated by local physicians [ Time Frame: at baseline and after 24 months ]
    evaluated by local physicians using a four point scale: excellent, good, regular, bad.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent according to ICH/GCP regulations prior to any trial specific procedures
  • Patients undergoing NSM or SSM and IBBR in the therapeutic or risk-reducing Setting
  • Ability to complete the Quality of Life questionnaires

Exclusion Criteria:

  • No indication for IBBR according to clinical judgment of the treating surgeon
  • Skin flaps inadequate for pre-pectoral IBBR.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04293146


Contacts
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Contact: Walter Weber, Prof. Dr. med +41 61 328 61 49 walter.weber@usb.ch
Contact: Martin Haug, Prof. Dr. med +41 61 265 7195 martin.haug@usb.ch

Locations
Show Show 21 study locations
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Swiss National Science Foundation
Investigators
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Principal Investigator: Walter Weber, Prof. Dr. med Division of Breast Surgery, University Hospital Basel
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT04293146    
Other Study ID Numbers: 2020-00256; ch18Weber4
First Posted: March 3, 2020    Key Record Dates
Last Update Posted: August 26, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Basel, Switzerland:
skin-sparing mastectomy (SSM)
nipple-sparing mastectomy (NSM)
immediate breast reconstruction
pre-pectoral breast implant
sub-pectoral breast implant