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Delayed-immediate Versus Delayed Breast Reconstruction in Breast Cancer Patients With Mastectomy and Radiation Therapy

Primary Purpose

Breast Neoplasm Female, Complication of Radiation Therapy, Breast Implant; Complications

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Delayed-immediate reconstruction
Delayed reconstruction
Sponsored by
Danish Breast Cancer Cooperative Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Neoplasm Female focused on measuring Breast cancer, Reconstruction, Post mastectomy radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Woman >18 years who are offered a mastectomy for invasive breast can-cer pT1-3, pN0-N3, M0 and wish reconstruction. The patient can be inclu-ded no matter the status of estrogen receptor, progesterone receptor, malignancy grade, and HER2 status.
  • The patient is a candidate for loco-regional radiation therapy according to national or institutional guidelines.
  • Highly selected patients with inflammatory breast cancer, namely those with complete or near complete response to neoadjuvant systemic thera-py judged by imaging and clinical examination before surgery. Any skin edema and clinical signs of skin involvement must have disappeared during systemic therapy. It is highly recommended that the decision to offer an inflammatory breast cancer patient inclusion in the DBCG RT Recon trial is made during a multidisciplinary team conference.
  • Adjuvant systemic therapy with chemotherapy, endocrine therapy, anti-HER2 treatment and other targeted therapies used in the adjuvant setting either as new standard or as part of a trial during the course of the trial is accepted.
  • Neoadjuvant chemotherapy and primary systemic therapy of an operable breast cancer is accepted.
  • Patient with previous non-breast malignancy is accepted if the patient has been without disease minimum 5 years, and the treating oncologist esti-mates a low risk of recurrence. Patients with the following diseases can be accepted despite less than 5 years disease free interval: carcinoma in situ cervicis, carcinoma in situ coli, melanoma in situ, basal cell carcino-ma of the skin, squamous cell carcinoma of the skin.
  • Life expectancy minimum 10 years.

Exclusion Criteria:

  • Pregnant or lactating.
  • Previous breast cancer or Ductal carcinoma in Situ (DCIS).
  • Bilateral breast cancer.
  • Previous radiation therapy to the chest region.
  • Previous non-breast malignancy (not including carcinoma in situ of the cervix or colon, melanoma in situ, basal cell carcinoma of the skin, and squamous cell carcinoma of the skin) within 5 years.
  • Conditions indicating that the patient cannot go through breast reconstruction, the radiation therapy or follow up.
  • Not being able to participate due to language or other personal issues.
  • Life expectancy less than 10 years.

Sites / Locations

  • Ålborg Universitetshospital
  • Rigshospitalet/Herlev HospitalRecruiting
  • Esbjerg SygehusRecruiting
  • Ringsted Sygehus
  • Viborg Sygehus
  • Åbenrå Sygehus
  • Århus Universitets Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A: Delayed-immediate reconstruction

B: Delayed reconstruction

Arm Description

Primary Surgery: Skin sparing mastectomy (nipple sparing if appropriate) and axillary surgery according to guidelines or protocol. Reconstruction with silicone implant or expander covered by pectoral muscle and mesh or matrix. Delayed reconstruction: Final reconstruction with any reconstructive procedure - being it autologous or implant-based (one- or two-stage, +/- acellular dermal matrix (ADM)) - is performed 6-12 months after completion of chemotherapy and PMRT. Any contralateral procedure is allowed when doing the delayed surgery, but not in relation to the initial cancer surgery.

Primary surgery: Total mastectomy and axillary surgery according to guidelines or protocol. Delayed reconstruction: 6-12 months after completion of PMRT: final recon-struction with any reconstructive procedure - being it autologous or implant-based (one-or two-stage, +/- ADM). Any contralateral procedure is allowed at any time point after PMRT has been delivered

Outcomes

Primary Outcome Measures

Number of patients with complications with surgical intervention
Number of patients with complication deeming surgical intervention necessary (excluding percutaneous drainage and antibiotic treatment for inflammation in cases without need for open drainage): Infection Hematoma Loss of implant/expander Necrosis Seroma

Secondary Outcome Measures

Number of patients with complications without surgical intervention
Number of patients with complication (Infection with need for antibiotics and/or necrosis) without intervention necessary
Depression
Degree of Depression measured by Becks Depression Inventory, BDII using a scale from 1 to 4, 4 being the worst
Fear of cancer recurrence
Fear of cancer recurrence measured by Concerns About Recurrence Questionnaire-3 (CARQ-3 ) on a scale from 1 to 10, 10 worst (fear all the time)
Patient´s satisfaction and quality of life (QoL)
Patient satisfaction and QoL measures by the BREAST-Q-instruments on a scale from 1 to 5, 5 being worst
Timely initiation of adjuvant therapy
Time from primary surgery to start of adjuvant therapy
Degree of patient reported morbidity regarding body image, painsensory disturbanses and feeling og lymphoedema
Patient reported morbidity measured by a questionnaire. The prevalence of pain will be assessed on a 0-10 numerical rating scale (NRS) and reported as: 'light pain' NRS 1-3; 'moderate pain' NRS 4-6; and 'severe pain' NRS 7-10. Sensory disturbances will be assessed by a dichotomous 'yes/no' question,. Lymphoedema will be assessed on a 0-10 numerical rating scale, 10 being worst. Body image will be assessed on a 0-7 numerical rating scale, 7 being best.
Number of patients with lymphoedema
Difference in arm circumference between arms 15 cm/10 cm proximal/distal to the olecranon bilaterally. Any difference ≥10% defines lymhoedema.
Number of patients with restricted range of motion of the shoulder
Differences between arms in range of motion of the shoulder measured at abduction/flexion with the patient sitting in front of a poster with a circle with degrees 0-180˚.Any difference ≥10 degrees defines defines restricted motion
Number of patients with capsular contracture
Degree of capsular Contracture using Baker grading
Aesthetic outcome
Aesthetic outcome scored bt the physician using breast Photo, on a scale from 0 to 3, 3 being worst

Full Information

First Posted
October 2, 2018
Last Updated
February 14, 2023
Sponsor
Danish Breast Cancer Cooperative Group
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1. Study Identification

Unique Protocol Identification Number
NCT03730922
Brief Title
Delayed-immediate Versus Delayed Breast Reconstruction in Breast Cancer Patients With Mastectomy and Radiation Therapy
Official Title
The DBCG RT Recon Trial: Delayed-immediate Versus Delayed Breast Reconstruction in Early Breast Cancer Patients Treated With Mastectomy and Adjuvant Loco-regional Radiation Therapy. A Multicenter Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2033 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Breast Cancer Cooperative Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In breast cancer patients treated by mastectomy and adjuvant post-mastectomy radiation therapy (PMRT) reconstruction is often delayed until 6 - 12 month after completion of chemotherapy and PMRT, due to high risk of complication. In this trial the safety of the delayed-immediate reconstruction method is tested, where a skin sparing mastectomy and reconstruction with silicone implant is performed at primary surgery to save the native skin for the final delayed reconstruction.
Detailed Description
An increasing proportion of breast cancer patients treated by mastectomy wish for a breast reconstruction. If post-mastectomy radiation therapy is recommended, the reconstruction is often delayed until 6 - 12 months after completion of chemotherapy and radiation therapy due to risk of complication that might delay adjuvant treatment. At this time the native skin over the removed breast cannot be used in the reconstruction, resulting in a suboptimal aesthetic outcome. In the delayed-immediate reconstruction method, a skin sparing mastectomy and reconstruction with implant is performed at primary surgery, to save the native skin under radiation therapy, thereby improving the chance for a good aesthetic outcome at the final delayed reconstruction. In this trial breast cancer patients treated by mastectomy and loco-regional radiation therapy is randomized to either delayed reconstruction or delayed-immediate reconstruction. The complication rate as well as morbidity, aesthetic outcome and psychological well-being after delayed-immediate reconstruction will be compared with delayed reconstruction

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm Female, Complication of Radiation Therapy, Breast Implant; Complications
Keywords
Breast cancer, Reconstruction, Post mastectomy radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
590 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A: Delayed-immediate reconstruction
Arm Type
Experimental
Arm Description
Primary Surgery: Skin sparing mastectomy (nipple sparing if appropriate) and axillary surgery according to guidelines or protocol. Reconstruction with silicone implant or expander covered by pectoral muscle and mesh or matrix. Delayed reconstruction: Final reconstruction with any reconstructive procedure - being it autologous or implant-based (one- or two-stage, +/- acellular dermal matrix (ADM)) - is performed 6-12 months after completion of chemotherapy and PMRT. Any contralateral procedure is allowed when doing the delayed surgery, but not in relation to the initial cancer surgery.
Arm Title
B: Delayed reconstruction
Arm Type
Active Comparator
Arm Description
Primary surgery: Total mastectomy and axillary surgery according to guidelines or protocol. Delayed reconstruction: 6-12 months after completion of PMRT: final recon-struction with any reconstructive procedure - being it autologous or implant-based (one-or two-stage, +/- ADM). Any contralateral procedure is allowed at any time point after PMRT has been delivered
Intervention Type
Procedure
Intervention Name(s)
Delayed-immediate reconstruction
Intervention Description
Skin sparing mastectomy and reconstruction with silicone implant or expander covered by pectoral muscle and mesh or matrix. Final reconstruction with any reconstructive procedure 6-12 months after completion of chemotherapy and RT.
Intervention Type
Procedure
Intervention Name(s)
Delayed reconstruction
Intervention Description
Total mastectomy and delayed reconstruction:with any reconstructive procedure 6-12 months after completion of PMRT
Primary Outcome Measure Information:
Title
Number of patients with complications with surgical intervention
Description
Number of patients with complication deeming surgical intervention necessary (excluding percutaneous drainage and antibiotic treatment for inflammation in cases without need for open drainage): Infection Hematoma Loss of implant/expander Necrosis Seroma
Time Frame
1 year after final reconstruction
Secondary Outcome Measure Information:
Title
Number of patients with complications without surgical intervention
Description
Number of patients with complication (Infection with need for antibiotics and/or necrosis) without intervention necessary
Time Frame
1 year after final reconstruction
Title
Depression
Description
Degree of Depression measured by Becks Depression Inventory, BDII using a scale from 1 to 4, 4 being the worst
Time Frame
10 years post-final reconstruction
Title
Fear of cancer recurrence
Description
Fear of cancer recurrence measured by Concerns About Recurrence Questionnaire-3 (CARQ-3 ) on a scale from 1 to 10, 10 worst (fear all the time)
Time Frame
10 years post-final reconstruction
Title
Patient´s satisfaction and quality of life (QoL)
Description
Patient satisfaction and QoL measures by the BREAST-Q-instruments on a scale from 1 to 5, 5 being worst
Time Frame
10 years post-final reconstruction
Title
Timely initiation of adjuvant therapy
Description
Time from primary surgery to start of adjuvant therapy
Time Frame
1 year
Title
Degree of patient reported morbidity regarding body image, painsensory disturbanses and feeling og lymphoedema
Description
Patient reported morbidity measured by a questionnaire. The prevalence of pain will be assessed on a 0-10 numerical rating scale (NRS) and reported as: 'light pain' NRS 1-3; 'moderate pain' NRS 4-6; and 'severe pain' NRS 7-10. Sensory disturbances will be assessed by a dichotomous 'yes/no' question,. Lymphoedema will be assessed on a 0-10 numerical rating scale, 10 being worst. Body image will be assessed on a 0-7 numerical rating scale, 7 being best.
Time Frame
10 years post-final reconstruction
Title
Number of patients with lymphoedema
Description
Difference in arm circumference between arms 15 cm/10 cm proximal/distal to the olecranon bilaterally. Any difference ≥10% defines lymhoedema.
Time Frame
10 years post-final reconstruction
Title
Number of patients with restricted range of motion of the shoulder
Description
Differences between arms in range of motion of the shoulder measured at abduction/flexion with the patient sitting in front of a poster with a circle with degrees 0-180˚.Any difference ≥10 degrees defines defines restricted motion
Time Frame
10 years post-final reconstruction
Title
Number of patients with capsular contracture
Description
Degree of capsular Contracture using Baker grading
Time Frame
10 years post-final reconstruction
Title
Aesthetic outcome
Description
Aesthetic outcome scored bt the physician using breast Photo, on a scale from 0 to 3, 3 being worst
Time Frame
10 years post-final reconstruction

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Woman >18 years who are offered a mastectomy for invasive breast can-cer pT1-3, pN0-N3, M0 and wish reconstruction. The patient can be inclu-ded no matter the status of estrogen receptor, progesterone receptor, malignancy grade, and HER2 status. The patient is a candidate for loco-regional radiation therapy according to national or institutional guidelines. Highly selected patients with inflammatory breast cancer, namely those with complete or near complete response to neoadjuvant systemic thera-py judged by imaging and clinical examination before surgery. Any skin edema and clinical signs of skin involvement must have disappeared during systemic therapy. It is highly recommended that the decision to offer an inflammatory breast cancer patient inclusion in the DBCG RT Recon trial is made during a multidisciplinary team conference. Adjuvant systemic therapy with chemotherapy, endocrine therapy, anti-HER2 treatment and other targeted therapies used in the adjuvant setting either as new standard or as part of a trial during the course of the trial is accepted. Neoadjuvant chemotherapy and primary systemic therapy of an operable breast cancer is accepted. Patient with previous non-breast malignancy is accepted if the patient has been without disease minimum 5 years, and the treating oncologist esti-mates a low risk of recurrence. Patients with the following diseases can be accepted despite less than 5 years disease free interval: carcinoma in situ cervicis, carcinoma in situ coli, melanoma in situ, basal cell carcino-ma of the skin, squamous cell carcinoma of the skin. Life expectancy minimum 10 years. Exclusion Criteria: Pregnant or lactating. Previous breast cancer or Ductal carcinoma in Situ (DCIS). Bilateral breast cancer. Previous radiation therapy to the chest region. Previous non-breast malignancy (not including carcinoma in situ of the cervix or colon, melanoma in situ, basal cell carcinoma of the skin, and squamous cell carcinoma of the skin) within 5 years. Conditions indicating that the patient cannot go through breast reconstruction, the radiation therapy or follow up. Not being able to participate due to language or other personal issues. Life expectancy less than 10 years.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tove F Tvedskov, DMSc
Phone
+4535451028
Email
tove.holst.filtenborg.tvedskov@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Peer M Christiansen, Professor
Email
peerchri@rm.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birgitte V Offersen, Professor
Organizational Affiliation
DBCG
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tove F Tvedskov, DMSc
Organizational Affiliation
DBCG
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tine Damsgaard, Professor
Organizational Affiliation
DBCG
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Peer Christiansen, Professor
Organizational Affiliation
DBCG
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Majbrit Jensen, MSc
Organizational Affiliation
DBCG
Official's Role
Study Director
Facility Information:
Facility Name
Ålborg Universitetshospital
City
Aalborg
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ute Hoyer
First Name & Middle Initial & Last Name & Degree
Lene Brink-Sørensen
First Name & Middle Initial & Last Name & Degree
Lars Lars Stenbygaard
Facility Name
Rigshospitalet/Herlev Hospital
City
Copenhagen
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tove Tvedskov
First Name & Middle Initial & Last Name & Degree
Rikke Bredgaard
First Name & Middle Initial & Last Name & Degree
Lisbeth Hölmich
First Name & Middle Initial & Last Name & Degree
Claus Kamby
First Name & Middle Initial & Last Name & Degree
Tine Damsgaard
Facility Name
Esbjerg Sygehus
City
Esbjerg
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lena Carstensen
Facility Name
Ringsted Sygehus
City
Ringsted
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lone Bak Hansen
Facility Name
Viborg Sygehus
City
Viborg
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Inge Scheel Andersen
Facility Name
Åbenrå Sygehus
City
Åbenrå
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jügen Handler
Facility Name
Århus Universitets Hospital
City
Århus
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peer Christiansen
First Name & Middle Initial & Last Name & Degree
Birgitte Vrou Offersen

12. IPD Sharing Statement

Citations:
PubMed Identifier
32988717
Citation
Kaidar-Person O, Nissen HD, Yates ES, Andersen K, Boersma LJ, Boye K, Canter R, Costa E, Daniel S, Hol S, Jensen I, Lorenzen EL, Mjaaland I, Nielsen MEK, Poortmans P, Vikstrom J, Webb J, Offersen BV. Postmastectomy Radiation Therapy Planning After Immediate Implant-based Reconstruction Using the European Society for Radiotherapy and Oncology-Advisory Committee in Radiation Oncology Practice Consensus Guidelines for Target Volume Delineation. Clin Oncol (R Coll Radiol). 2021 Jan;33(1):20-29. doi: 10.1016/j.clon.2020.09.004. Epub 2020 Sep 26.
Results Reference
derived

Learn more about this trial

Delayed-immediate Versus Delayed Breast Reconstruction in Breast Cancer Patients With Mastectomy and Radiation Therapy

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