Clinical trial · Observational
Evaluation of Medical Treatments in MBC Patients According Biological Subtype and Line of Treatments
Evaluation of Medical Treatments (Chemotherapy, Hormonal Therapy and Biological Therapies) in Metastatic Breast Cancer Patients According to Biologic Subtype and Line of Treatment
- 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)
Breast cancer is the most common cancer in many countries: in Italy about 48.000 new breast cancers are diagnosed every year and, despite improvements in diagnosis and therapy, about 13.000 women die every year for this disease . About 6-7% of breast cancer patients are metastatic at diagnosis , while the majority of patients with stage IV has a previous history of breast cancer that has already been treated. According to various prognostic factors (tumor size, lymph nodes involvement, grading, hormone receptors status, HER-2 status), in the worst-case scenario, more than 30% of node-negative breast cancer patients and more than 70% of node-positive patients relapse2. The evolution of metastatic breast cancer has changed considerably in the last years with the approval of new drugs. In fact, already in 2003 Giordano et al showed that the prognosis of metastatic breast cancer patients was improved significantly from 1970's to 2000 with a median survival of 15 months in the early 1970's compared with 60 months in the last 1990's. This significant survival gain was obtained with introduction of new drugs as hormonal, chemotherapeutic and biological agents. The greater availability of drugs has led to an increase in number of lines of treatment receiving by metastatic breast cancer patients. However, there are few published data on actual duration of metastatic breast cancer treatments. Moreover, there is no evidence to support a real impact on survival of treatments beyond the second-third line. Recently, a retrospective analysis of about 199 metastatic breast cancer patients treated with chemotherapy showed that tumor subtype is associated with the duration and number of lines of chemotherapy (for example HER positive versus "triple-negative" patients) .
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 (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Retrospective cohort
- description
- All consecutive metastatic breast cancers patients treated in the participating site with a first-line therapy (chemotherapy or hormonal therapy with or without biological therapy) from last contact with patient or death which ever event comes first retrospectively back until 1st of January 2000.
- label
- Prospective cohort
- description
- All new consecutive metastatic breast cancers patients will be treated in the participating site with a first-line therapy (chemotherapy or hormonal therapy with or without biological therapy) from site activation to June 2023.
Primary outcomes (1)
- measure
- Duration and number of lines' treatment
- timeFrame
- Retrospectively from 2000 up to site activation; prospectively assested up to 32 months
Secondary outcomes (4)
- measure
- Overall Survival according duration
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Retrospective cohort All consecutive metastatic breast cancers patients treated in the participating site with a first-line therapy (chemotherapy or hormonal therapy with or without biological therapy) from last contact with patient or death which ever event comes first retrospectively back until 1 st of January 2000 Prospective cohort All new consecutive metastatic breast cancers patients will be treated in the participating site with a first-line therapy (chemotherapy or hormonal therapy with or without biological therapy)from site activation to June 2023. For the ancillary study * Patients eligible for GIM 14 - BIO-META study * HR+ HER2- patients newly diagnosed for mBC receiving CDk4/6 inhibitors as first-line or second-line treatment * Written informed consent Exclusion Criteria: Not consecutive metastatic breast cancer patients grouped for a particular biological type (for example: all HER2 positive patients).
References
Publications (5)
- BACKGROUNDCardoso F, Senkus-Konefka E, Fallowfield L, Costa A, Castiglione M; ESMO Guidelines Working Group. Locally recurrent or metastatic breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2010 May;21 Suppl 5:v15-9. doi: 10.1093/annonc/mdq160. No abstract available. PMID 20555067
- BACKGROUNDSchnipper LE, Smith TJ, Raghavan D, Blayney DW, Ganz PA, Mulvey TM, Wollins DS. American Society of Clinical Oncology identifies five key opportunities to improve care and reduce costs: the top five list for oncology. J Clin Oncol. 2012 May 10;30(14):1715-24. doi: 10.1200/JCO.2012.42.8375. Epub 2012 Apr 3. No abstract available. PMID 22493340
- BACKGROUNDSeah DS, Luis IV, Macrae E, Sohl J, Litsas G, Winer EP, Lin NU, Burstein HJ. Use and duration of chemotherapy in patients with metastatic breast cancer according to tumor subtype and line of therapy. J Natl Compr Canc Netw. 2014 Jan;12(1):71-80. doi: 10.6004/jnccn.2014.0008. PMID 24453294
- BACKGROUNDGoldhirsch A, Wood WC, Coates AS, Gelber RD, Thurlimann B, Senn HJ; Panel members. Strategies for subtypes--dealing with the diversity of breast cancer: highlights of the St. Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2011. Ann Oncol. 2011 Aug;22(8):1736-47. doi: 10.1093/annonc/mdr304. Epub 2011 Jun 27. PMID 21709140
- DERIVEDConte B, Fabi A, Poggio F, Blondeaux E, Dellepiane C, D'Alonzo A, Buono G, Arpino G, Magri V, Naso G, Presti D, Mura S, Fontana A, Cognetti F, Molinelli C, Pastorino S, Bighin C, Miglietta L, Boccardo F, Lambertini M, Del Mastro L; Gruppo Italiano Mammella (GIM) study group. T-DM1 Efficacy in Patients With HER2-positive Metastatic Breast Cancer Progressing After a Taxane Plus Pertuzumab and Trastuzumab: An Italian Multicenter Observational Study. Clin Breast Cancer. 2020 Apr;20(2):e181-e187. doi: 10.1016/j.clbc.2019.09.001. Epub 2019 Nov 14. PMID 31735691