Clinical trial · Interventional
Reconstruction of Partial Mastectomy Defects With Pectoralis Myo-glandular Local Flap.
Reconstruction of Partial Mastectomy Defects With Myo-glandular Local Flap: Pilot Study.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Increasing number of breast cancer patients are being treated with conservative surgery; without the need for mastectomy. The cosmetic sequel of breast conservative surgery can be unsatisfactory to the patient and may necessitate secondary surgery. The present study aims at improving the cosmetic outcome of breast conservative surgery. The defect remaining in the breast tissue after excision of the tumour will be filled with the underlying pectoralis major muscle. This pilot study will test the safety and efficacy of using the pectoralis major muscle for reconstructing a partial mastectomy defect. fifteen patients with early breast cancer scheduled for breast conservation will be recruited to this study.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pectoralis myo-glandular flap reconstruction. | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Post-tumourectomy reconstruction with myo-glandular flap.
- description
- Standard tumourectomy followed by reconstruction with myo-glandular flap.
- interventionNames
- Procedure: Pectoralis myo-glandular flap reconstruction.
Primary outcomes (2)
- measure
- The rate of major complications
- timeFrame
- Six weeks after surgery.
- description
- The rate of major complications related to surgery that necessitate further intervention.
- measure
- The score of early cosmetic outcome
- timeFrame
- Six weeks after surgery.
- description
- This is a categorical variable. The cosmetic score is reported according to the Harris method. In this method the overall cosmetic result is ranked as one of four scores. The maximum score is "Excellent" where the treated breast is identical to the other breast. Slight difference is scored as "Good". Marked difference without distortion is scored as " Fair". The least score is " Poor" where there is breast distortion.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with early breast cancer or phylloides tumor. 2. Eligible for breast conservative surgery. 3. Expected post-lumpectomy volume loss of 20-40% of breast volume. 4. Tumor location in upper quadrants. 5. Informed consent. Exclusion Criteria: 1. Patient refusal. 2. Contraindication of breast conservative therapy: 1. Pregnancy. 2. Diffuse microcalcifications. 3. Patient choice for mastectomy. 4. Collagen / vascular disease. 5. Multicentric tumor. 3. Psychological co-morbidity.
References
Publications (3)
- BACKGROUNDHarris JR, Levene MB, Svensson G, Hellman S. Analysis of cosmetic results following primary radiation therapy for stages I and II carcinoma of the breast. Int J Radiat Oncol Biol Phys. 1979 Feb;5(2):257-61. doi: 10.1016/0360-3016(79)90729-6. No abstract available. PMID 110740
- BACKGROUNDTobin GR. Pectoralis major segmental anatomy and segmentally split pectoralis major flaps. Plast Reconstr Surg. 1985 Jun;75(6):814-24. doi: 10.1097/00006534-198506000-00009. PMID 4001201
- BACKGROUNDFisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, Jeong JH, Wolmark N. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002 Oct 17;347(16):1233-41. doi: 10.1056/NEJMoa022152. PMID 12393820