Clinical trial · Interventional
Assessing Impact of Loco-regional Treatment on Survival in Metastatic Breast Cancer at Presentation
A Randomized Trial To Assess The Impact Of Loco-Regional Treatment On Survival Of Patients With Metastatic Breast Cancer At First Presentation
- 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)
Traditionally metastatic breast cancer patients are not offered loco-regional treatment except in cases of fungation or bleeding. However, scientific evidence for such omission of loco-regional treatment in metastatic breast cancer patients is lacking. On one hand, studies have shown that removal of primary tumor at times leads to complete disappearance of metastases and improvement in survival in renal cell carcinoma patients. However, such studies have never been performed in other solid tumors. On the other hand, there is a strong body of evidence in experimental settings that show that removal of primary tumor allows growth of metastasis. There is lack of similar data in humans in clinical settings. Offering loco-regional treatment in metastatic breast cancer patients in a setting of randomized controlled trial will help in improving survival of such patients and understanding the natural history of breast cancer.
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 |
|---|---|---|---|
| Cancer of the Breast | Malignant Breast Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No Loco-regional treatment | Other | — | UNRESOLVED |
| Surgery for breast cancer | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Loco Regional Treatment Arm (LRT)
- description
- Surgery for breast cancer. (MRM/BCT)
- interventionNames
- Procedure: Surgery for breast cancer
- type
- ACTIVE_COMPARATOR
- label
- No Loco-regional Treatment Arm
- description
- No surgery for Breast cancer
- interventionNames
- Other: No Loco-regional treatment
Primary outcomes (2)
- measure
- Overall survival
- timeFrame
- 3 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Metastatic breast cancer at first presentation with an expected survival of at least one year Exclusion Criteria: 1. Patients who are not fit to receive anthracycline based chemotherapy. 2. More than two visceral organ involvement. 3. Multiple liver metastases with deranged liver function tests (SGOT/SGPT more than four times the upper normal limit). 4. Locally static or progressive disease or systemically progressive disease as shown by repeat staging investigations guided by worsening symptoms. 5. Ulceration/ fungation/ bleeding after completion of chemotherapy, which mandates surgery. 6. Expected survival of less than six months after completion of chemotherapy. 7. Unfit for anaesthesia due to metastatic disease.
References
Publications (9)
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- BACKGROUNDMickisch GH, Garin A, van Poppel H, de Prijck L, Sylvester R; European Organisation for Research and Treatment of Cancer (EORTC) Genitourinary Group. Radical nephrectomy plus interferon-alfa-based immunotherapy compared with interferon alfa alone in metastatic renal-cell carcinoma: a randomised trial. Lancet. 2001 Sep 22;358(9286):966-70. doi: 10.1016/s0140-6736(01)06103-7. PMID 11583750
- BACKGROUNDFisher B, Gunduz N, Coyle J, Rudock C, Saffer E. Presence of a growth-stimulating factor in serum following primary tumor removal in mice. Cancer Res. 1989 Apr 15;49(8):1996-2001. PMID 2702641
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- BACKGROUNDHori A, Sasada R, Matsutani E, Naito K, Sakura Y, Fujita T, Kozai Y. Suppression of solid tumor growth by immunoneutralizing monoclonal antibody against human basic fibroblast growth factor. Cancer Res. 1991 Nov 15;51(22):6180-4. PMID 1718597
- BACKGROUNDO'Reilly MS, Holmgren L, Shing Y, Chen C, Rosenthal RA, Moses M, Lane WS, Cao Y, Sage EH, Folkman J. Angiostatin: a novel angiogenesis inhibitor that mediates the suppression of metastases by a Lewis lung carcinoma. Cell. 1994 Oct 21;79(2):315-28. doi: 10.1016/0092-8674(94)90200-3.