Clinical trial · Observational
Observation of Medical Treatments in MBC HER2-negative Patients
Evaluation of Medical Treatments in MBC HER2 Negative Patients in Italy - Observational 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)
While therapeutic strategies for HER2-positive breast cancer are well defined, there is not a standard strategy for HER2-negative tumors. Because of lack of information related to the the factors affecting the choice of a particular treatment strategy, as well as the optimization of the correct sequence of treatments, the choice of the treatment for the advanced disease remains highly empirical and may differ significantly among the different cancer centers. The purpose of this study is the observation of a cohort of patients with metastatic HER2-negative in terms of: 1. the choice of chemotherapy treatments starting from the first line of treatment; 2. factors that may influence these choices; 3. correlation among the characteristics of patients (age, menopausal status, etc.) and type of adjuvant and metastatic treatment ; 4. clinical outcome (pattern of relapse, time from diagnosis, etc.); 5. evaluation of the adherence to the literature's recommendations for therapeutic sequences in clinical practice.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Observation of treatment management | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Prospective
- description
- Observation of treatment management of patients with metastatic breast cancer that have been treated or not with hormonal therapy and candidate for a first line chemotherapeutic treatment in the years 2014-2015 will be observed until the end of the study.
- interventionNames
- Other: Observation of treatment management
- label
- Retrospective
- description
- Observation of treatment management of patients with metastatic breast cancer that have been treated with a first, second or following line of chemotherapeutic treatment for metastatic disease in the years 2012-2013.
- interventionNames
- Other: Observation of treatment management
Primary outcomes (1)
- measure
- Number subsequent lines of treatment.
- timeFrame
- Outcome 1 assessed up to 24 months (2012 until 2016 where applicable)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with HER2-negative metastatic breast cancer (Stage IV), that have received or not the endocrine therapy for the metastatic disease and that are candidate for the first-line chemotherapy treatment in the years 2014-2015 (prospective cohort), or patients that have received a treatment of first, second or subsequent-line of chemotherapy for the metastatic disease in the years 2012-2013 (retrospective cohort). 2. Age \> 18 years 3. Availability of all information required by the study, in particular: * histology * hormone receptor status * grading * stage of disease at diagnosis * type of surgery for the primary tumor * type of adjuvant therapy (chemotherapy or hormone therapy) * type of medication received as adjuvant therapy * date and seat of the relapse * type of treatment received for the first / second / third-line of treatment of metastatic disease (chemotherapy or hormone therapy) * type of chemotherapy regimen used and details about the medication, date and seat of disease progression 4. Written informed consent (in case of the impossibility to obtain the consent in writing, eg, death of the patient, the data will be collected as required by the Guarantor, OJ N.72 of March 26, 2012) Exclusion Criteria: 1. Patients with metastatic disease at diagnosis 2. Patients with HER2-positive breast 3. Participation in clinical research protocols, both for the retrospective cohort and for the perspective one
References
Publications (14)
- BACKGROUNDPerez EA, Suman VJ, Davidson NE, Gralow JR, Kaufman PA, Visscher DW, Chen B, Ingle JN, Dakhil SR, Zujewski J, Moreno-Aspitia A, Pisansky TM, Jenkins RB. Sequential versus concurrent trastuzumab in adjuvant chemotherapy for breast cancer. J Clin Oncol. 2011 Dec 1;29(34):4491-7. doi: 10.1200/JCO.2011.36.7045. Epub 2011 Oct 31. PMID 22042958
- BACKGROUNDCazzaniga ME, Mustacchi G, Pronzato P, De Matteis A, Di Costanzo F, Floriani I; NORA Study Group. Adjuvant systemic treatment of early breast cancer: the NORA study. Ann Oncol. 2006 Sep;17(9):1386-92. doi: 10.1093/annonc/mdl132. Epub 2006 Jun 21. PMID 16790520
- BACKGROUNDSmith I, Procter M, Gelber RD, Guillaume S, Feyereislova A, Dowsett M, Goldhirsch A, Untch M, Mariani G, Baselga J, Kaufmann M, Cameron D, Bell R, Bergh J, Coleman R, Wardley A, Harbeck N, Lopez RI, Mallmann P, Gelmon K, Wilcken N, Wist E, Sanchez Rovira P, Piccart-Gebhart MJ; HERA study team. 2-year follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer: a randomised controlled trial. Lancet. 2007 Jan 6;369(9555):29-36. doi: 10.1016/S0140-6736(07)60028-2. PMID 17208639
- RESULTO'Shaughnessy JA, Brufsky AM. RiBBON 1 and RiBBON 2: phase III trials of bevacizumab with standard chemotherapy for metastatic breast cancer. Clin Breast Cancer. 2008 Aug;8(4):370-3. doi: 10.3816/CBC.2008.n.045. No abstract available. PMID 18757267
- RESULTSlamon D, Eiermann W, Robert N, Pienkowski T, Martin M, Press M, Mackey J, Glaspy J, Chan A, Pawlicki M, Pinter T, Valero V, Liu MC, Sauter G, von Minckwitz G, Visco F, Bee V, Buyse M, Bendahmane B, Tabah-Fisch I, Lindsay MA, Riva A, Crown J; Breast Cancer International Research Group. Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med. 2011 Oct 6;365(14):1273-83. doi: 10.1056/NEJMoa0910383. PMID 21991949
- RESULTPiccart-Gebhart MJ, Procter M, Leyland-Jones B, Goldhirsch A, Untch M, Smith I, Gianni L, Baselga J, Bell R, Jackisch C, Cameron D, Dowsett M, Barrios CH, Steger G, Huang CS, Andersson M, Inbar M, Lichinitser M, Lang I, Nitz U, Iwata H, Thomssen C, Lohrisch C, Suter TM, Ruschoff J, Suto T, Greatorex V, Ward C, Straehle C, McFadden E, Dolci MS, Gelber RD; Herceptin Adjuvant (HERA) Trial Study Team. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med. 2005 Oct 20;353(16):1659-72. doi: 10.1056/NEJMoa052306.