An interventional study of Delayed-immediate reconstruction and Delayed reconstruction in Breast Neoplasm Female, Complication of Radiation Therapy and Breast Implant; Complications, sponsored by Danish Breast Cancer Cooperative Group. Recruiting at 8 sites in Denmark. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-06.
Sponsored by Danish Breast Cancer Cooperative Group · Not applicable, Interventional, and Treatment
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.
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
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 590 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Danish Breast Cancer Cooperative Group is the lead sponsor of 12 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Delayed-immediate reconstruction
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 This arm has been closed nov 2023
Procedure: Delayed reconstruction
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.
Total mastectomy and delayed reconstruction:with any reconstructive procedure 6-12 months after completion of PMRT
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
Time frame: 1 year after final reconstruction
Number of patients with complications without surgical intervention
Number of patients with complication (Infection with need for antibiotics and/or necrosis) without intervention necessary
Time frame: 1 year after final reconstruction
Depression
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
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)
Time frame: 10 years post-final reconstruction
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
Time frame: 10 years post-final reconstruction
Timely initiation of adjuvant therapy
Time from primary surgery to start of adjuvant therapy
Time frame: 1 year
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.
Time frame: 10 years post-final reconstruction
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.
Time frame: 10 years post-final reconstruction
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
Time frame: 10 years post-final reconstruction
Number of patients with capsular contracture
Degree of capsular Contracture using Baker grading
Time frame: 10 years post-final reconstruction
Aesthetic outcome
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
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Started Jan 2020 (actual). Primary completion is estimated for Nov 2025, 70 months after the start.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 70 months is above that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
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Danish Breast Cancer Cooperative Group