A Phase 3 interventional study of Bracketing and Neoadjuvant therapy in Breast Cancer, sponsored by Mansoura University. Recruiting at 1 site in Egypt. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-25.
Sponsored by Mansoura University · Phase 3, Interventional, and Treatment
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Among 22 studies in Breast Neoplasms by Mansoura University — 3 open to participants now, 4 under way, 1 of them phase 3. Breast Neoplasms · Mansoura University.
Among the 22 studies in Breast Neoplasms by Mansoura University, this one has the largest planned enrollment of the 18 interventional ones that give a count, is one of 3 that started in 2019, is one of 2 in phase 3, and was the 5th registered.
14,832 studies on the registry are indexed under Breast Neoplasms; 3,320 are open to participants now.
Browse Breast Neoplasms studies →3 of the 22 studies in Breast Neoplasms by Mansoura University are open now, in 1 country. Recruiting first, the newest first:
Mansoura University · Sites in Egypt
Ages 18–70 · Women only
Mansoura University · Sites in Egypt
Ages 19+
By country, each count listing its studies:
Of the 2,399 Breast Neoplasms studies recruiting now, 1,570 (65%) set no upper age limit and 592 (25%) stop at 75 or younger; 103 take children under 18; 215 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
22 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 9 · Phase 3 5 · Phase 4 1
First in 2005; this study’s year is marked. 3 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 370 is above the median of 72 across 10,903 interventional studies indexed under Breast Neoplasms.
Median enrollment 71 across the 18 interventional studies, 30 across the 3 observational. Of the 9 that completed or were terminated, 2 (22%) have results posted.
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Mansoura University is the lead sponsor of 1,119 studies on the registry; 183 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
1 of the studies in Breast Neoplasms by Mansoura University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07929441Mansoura UniversityRetro-SCTL Space Block vs Rhomboid Intercostal Block for Analgesia After Modified Radical Mastectomy | 2027-04-20 |
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Among the 22 studies in Breast Neoplasms by Mansoura University, from their registry updates:
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Breast cancer patients often receive systemic drugs as the initial curative treatment of their disease. The initial systemic therapy leads to a variable degree of tumor shrinkage. At present, there is no evidence-based consensus among breast surgeons on the optimal extent of resection after considerable tumor shrinkage and whether resection margin should be designed according to the tumor extent before treatment or the extent after treatment. This trial will help determine the optimal extent of resection in tumors that exhibits a significant change in volume after primary systemic therapy.
Primary systemic (neoadjuvant) therapy (NAT) is a widely practised curative treatment for invasive breast cancer. Neoadjuvant chemotherapy (before surgery) and adjuvant chemotherapy (after surgery) had equivalent survival rates in major randomized trials. In these studies, preoperative systemic therapy increased the patient's chance to achieve breast conservation. The down side was a clear trend towards increased ipsilateral breast tumor recurrence. Preoperative chemotherapy leads to patchy, irregular cell death known as honeycomb effect and thus may lead to a misleading false negative resection margin of a tumorectomy operation. Even with the advent of oncoplastic techniques which allowed larger resection volumes with satisfactory cosmetic results, rates of re-excision, mastectomy and local relapse did not differ from those after traditional lumpectomy operations. As of today, there is no consensus -based on evidence- on the optimal width of margin in patients who are offered breast conservative surgery (BCS) after systemic therapy. In view of the current uncertainty and lack of evidence, The present trial is designed to answer the following question (Specific aim): Does planning the resection margin according to the pre-treatment tumor extent improve the local recurrence rate in patients receiving breast conservative surgery after systemic therapy?
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.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Lumpectomy is performed with resection margin of the clinically / radiologically identifiable post-treatment tumor.
Procedure: Bracketing · Drug: Neoadjuvant therapy · Procedure: Post-treatment volume margin resection
Lumpectomy is performed with resection margin of the bracketed tissue.
Procedure: Bracketing · Drug: Neoadjuvant therapy · Procedure: Pre-treatment volume margin resection
At the beginning of therapy, ultrasonographic examination is used to measure the tumor in three dimensions and bracket the tumor using 4-6 metal clips which will serve as markers for the initial tumor extent in case of tumor shrinkage in response to systemic treatment.
All patients will receive primary systemic therapy according to the current institutional guidelines. Drugs include cytotoxic chemotherapy, hormonal therapy and/or anti-HER2/neu therapy as indicated.
The lumpectomy resection margin is planned according to the identifiable tumor at operation. The initial extent of the tumor at diagnosis is not taken in account. If there is complete clinical response to systemic therapy (i.e. no identifiable tumor), the center of the bracketed tissue is biopsied.
The lumpectomy includes the whole bracketed tissue to take in account the initial tumor extent before systemic therapy.
Local recurrence rate.
The rate of local recurrence at five years.
Time frame: at 60 months after the date of diagnosis.
Local disease-free survival.
The proportion of patients who remain free of local disease recurrence.
Time frame: up to 60 months from the date of diagnosis.
Disease-free survival.
The proportion of patients who remain free of disease recurrence.
Time frame: up to 60 months from the date of diagnosis.
Overall survival.
The proportion of patients who are alive.
Time frame: up to 60 months from the date of diagnosis.
Mastectomy rate.
The proportion of patients who undergo mastectomy after failed conservative surgery.
Time frame: at 6 months from the date of first surgical intervention.
Cosmetic score.
Numeric score description of the cosmetic outcome of breast conservative surgery.
Time frame: at 6 months from the date of first surgical intervention.
Plan to share: Undecided
Started Aug 2019 (actual). Primary completion is estimated for Aug 2026, 84 months after the start.
Of 328 non-industry phase 3 interventional studies under Breast Neoplasms, half reached primary completion within 79 months of starting (the median), counting those still running; a quarter within 50 and three quarters within 127. This study's planned 84 months is close to that.
Counting every sponsor, half of 600 studies reached it within 59 months; a quarter within 36 and three quarters within 96.
How these figures are worked out, and which studies are left out of them.
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