Clinical trial · Interventional
Study of Impact of Routine "Clinical Cancer Department/Supportive Care Department" Consultation on the Prescription of an Additional Line of Chemotherapy
Randomized Controlled Trial Assessing the Impact of Routine "Oncologist-supportive Care Team" Consultation on the Use of an Additional Line of Chemotherapy in Metastatic Breast Cancer Patients
- 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)
The purpose of this study is to assess the impact of systematic "clinical cancer department/supportive care department" consultation meetings, versus standard care, on the prescription of an additional line of chemotherapy in patients with metastatic breast cancer and visceral involvement after 3 or 4 lines of chemotherapy. This is a prospective paucicentric open label randomized controlled study with 2 parallel arms. Eligible patients will be randomly assigned to either arm "Study group" or "Standard care". The number of patients required to demonstrate a 30% reduction of the number of prescriptions for an additional line chemotherapy, assuming an alpha risk of 5% and 80% power, is 100 (50 in each arm).
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 |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Action Group | Other | — | UNRESOLVED |
| Standard care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Action Group
- interventionNames
- Other: Action Group
- type
- OTHER
- label
- Standard care
- interventionNames
- Other: Standard care
Primary outcomes (1)
- measure
- Rate of prescriptions for a 4th or 5th line of chemotherapy
- timeFrame
- At the time of progression on 3rd or 4th line of chemotherapy.
- description
- When patients progress under 3rd or 4th line of chemotherapy, rate of prescriptions for a 4th or 5th line will be collected.
Secondary outcomes (9)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Woman aged \>= 18 years * Metastatic breast cancer with visceral involvement * Patient requiring a 3rd or a 4th line of chemotherapy * Patient followed at Léon Bérard Cancer Center * Patient affiliated with social security * Patient able to read and write French * Written, voluntary, informed consent Exclusion Criteria: * Ongoing chemotherapy other than third or fourth line * Only skin or bone metastasis * Follow-up impossible for social, geographical, familial or psychological reasons * Patient deprived of freedom * Pregnant or lactating woman
References
Publications (29)
- BACKGROUNDGennari A, Conte P, Rosso R, Orlandini C, Bruzzi P. Survival of metastatic breast carcinoma patients over a 20-year period: a retrospective analysis based on individual patient data from six consecutive studies. Cancer. 2005 Oct 15;104(8):1742-50. doi: 10.1002/cncr.21359. PMID 16149088
- BACKGROUNDSlamon DJ, Leyland-Jones B, Shak S, Fuchs H, Paton V, Bajamonde A, Fleming T, Eiermann W, Wolter J, Pegram M, Baselga J, Norton L. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 2001 Mar 15;344(11):783-92. doi: 10.1056/NEJM200103153441101. PMID 11248153
- BACKGROUNDGiordano SH, Buzdar AU, Smith TL, Kau SW, Yang Y, Hortobagyi GN. Is breast cancer survival improving? Cancer. 2004 Jan 1;100(1):44-52. doi: 10.1002/cncr.11859. PMID 14692023
- BACKGROUNDBanerji U, Kuciejewska A, Ashley S, Walsh G, O'Brien M, Johnston S, Smith I. Factors determining outcome after third line chemotherapy for metastatic breast cancer. Breast. 2007 Aug;16(4):359-66. doi: 10.1016/j.breast.2007.01.004. Epub 2007 May 16. PMID 17509879
- BACKGROUNDRha SY, Moon YH, Jeung HC, Kim YT, Sohn JH, Yang WI, Suh CO, Kim GE, Roh JK, Chung HC. Gemcitabine monotherapy as salvage chemotherapy in heavily pretreated metastatic breast cancer. Breast Cancer Res Treat. 2005 Apr;90(3):215-21. doi: 10.1007/s10549-004-2468-4. PMID 15830134
- BACKGROUNDDufresne A, Pivot X, Tournigand C, Facchini T, Altweegg T, Chaigneau L, De Gramont A. Impact of chemotherapy beyond the first line in patients with metastatic breast cancer. Breast Cancer Res Treat. 2008 Jan;107(2):275-9. doi: 10.1007/s10549-007-9550-7. Epub 2007 Mar 23. PMID 17380382
- BACKGROUNDDetmar SB, Muller MJ, Schornagel JH, Wever LD, Aaronson NK. Role of health-related quality of life in palliative chemotherapy treatment decisions. J Clin Oncol. 2002 Feb 15;20(4):1056-62. doi: 10.1200/JCO.2002.20.4.1056.