Observation of Medical Treatments in MBC HER2-negative Patients

NCT02365831 | Unknown DMC

• 1 other identifier: GIM13-AMBRA
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.the choice of chemotherapy treatments starting from the first line of treatment;
2. 2.factors that may influence these choices;
3. 3.correlation among the characteristics of patients (age, menopausal status, etc.) and type of adjuvant and metastatic treatment ;
4. 4.clinical outcome (pattern of relapse, time from diagnosis, etc.);
5. 5.evaluation of the adherence to the literature's recommendations for therapeutic sequences in clinical practice.

Conditions

Metastatic Breast Cancer

Keywords

MBC; breast; metastatic; cancer; HER2

Outcome Measures

Primary Outcomes (1)

• Number subsequent lines of treatment.

  Evaluation of correlation between treatment choice and patient characteristic ( age, menopausal status, comorbidity).

  Outcome 1 assessed up to 24 months (2012 until 2016 where applicable)

Secondary Outcomes (3)

• Time to Treatment Change

  Outcome 2 assessed up to 24 months (2012 until 2016 where applicable)

• Correlation between the type of adjuvant therapy and the type of response to the treatment

  Outcome 3 assessed up to 24 months (2012 until 2016 where applicable)

• Evaluation of the adherence to the Consensus Conferences and Guidelines concerning the choice between the sequential therapies versus the combination therapies ( first, second, third line)

  Outcome 4 assessed up to 24 months (2012 until 2016 where applicable)

Study Arms (2)

Prospective

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.

Other: Observation of treatment management

Retrospective

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.

Other: Observation of treatment management

Interventions

Observation of treatment management OTHER

Group/cohort

Prospective; Retrospective

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female patients from Italy with metastatic breast cancer.

You may qualify if:

• 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).
• Age \> 18 years
• 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
• 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)

You may not qualify if:

• Patients with metastatic disease at diagnosis
• Patients with HER2-positive breast
• Participation in clinical research protocols, both for the retrospective cohort and for the perspective one

Sponsors & Collaborators

• Consorzio Oncotech: lead
• Clinical Research Technology S.r.l.: collaborator

Study Sites (1)

A.O. San Gerardo

Monza, 20900, Italy

RECRUITING

Related Publications (14)

• Perez 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 BACKGROUND

• Cazzaniga 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 BACKGROUND

• Smith 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 BACKGROUND

• O'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 RESULT

• Slamon 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 RESULT

• Piccart-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.

  PMID: 16236737 RESULT

• Gianni L, Dafni U, Gelber RD, Azambuja E, Muehlbauer S, Goldhirsch A, Untch M, Smith I, Baselga J, Jackisch C, Cameron D, Mano M, Pedrini JL, Veronesi A, Mendiola C, Pluzanska A, Semiglazov V, Vrdoljak E, Eckart MJ, Shen Z, Skiadopoulos G, Procter M, Pritchard KI, Piccart-Gebhart MJ, Bell R; Herceptin Adjuvant (HERA) Trial Study Team. Treatment with trastuzumab for 1 year after adjuvant chemotherapy in patients with HER2-positive early breast cancer: a 4-year follow-up of a randomised controlled trial. Lancet Oncol. 2011 Mar;12(3):236-44. doi: 10.1016/S1470-2045(11)70033-X. Epub 2011 Feb 25.

  PMID: 21354370 RESULT

• Clavarezza M, Mustacchi G, Casadei Gardini A, Del Mastro L, De Matteis A, Riccardi F, Adamo V, Aitini E, Amoroso D, Marchetti P, Gori S, Carrozza F, Maiello E, Giotta F, Dondi D, Venturini M. Biological characterization and selection criteria of adjuvant chemotherapy for early breast cancer: experience from the Italian observational NEMESI study. BMC Cancer. 2012 Jun 6;12:216. doi: 10.1186/1471-2407-12-216.

  PMID: 22672524 RESULT

• Gennari A, Stockler M, Puntoni M, Sormani M, Nanni O, Amadori D, Wilcken N, D'Amico M, DeCensi A, Bruzzi P. Duration of chemotherapy for metastatic breast cancer: a systematic review and meta-analysis of randomized clinical trials. J Clin Oncol. 2011 Jun 1;29(16):2144-9. doi: 10.1200/JCO.2010.31.5374. Epub 2011 Apr 4.

  PMID: 21464403 RESULT

• Kennecke H, Yerushalmi R, Woods R, Cheang MC, Voduc D, Speers CH, Nielsen TO, Gelmon K. Metastatic behavior of breast cancer subtypes. J Clin Oncol. 2010 Jul 10;28(20):3271-7. doi: 10.1200/JCO.2009.25.9820. Epub 2010 May 24.

  PMID: 20498394 RESULT

• Arvold ND, Taghian AG, Niemierko A, Abi Raad RF, Sreedhara M, Nguyen PL, Bellon JR, Wong JS, Smith BL, Harris JR. Age, breast cancer subtype approximation, and local recurrence after breast-conserving therapy. J Clin Oncol. 2011 Oct 10;29(29):3885-91. doi: 10.1200/JCO.2011.36.1105. Epub 2011 Sep 6.

  PMID: 21900114 RESULT

• Beslija S, Bonneterre J, Burstein HJ, Cocquyt V, Gnant M, Heinemann V, Jassem J, Kostler WJ, Krainer M, Menard S, Petit T, Petruzelka L, Possinger K, Schmid P, Stadtmauer E, Stockler M, Van Belle S, Vogel C, Wilcken N, Wiltschke C, Zielinski CC, Zwierzina H; Central European Cooperative Oncology Group (CECOG). Third consensus on medical treatment of metastatic breast cancer. Ann Oncol. 2009 Nov;20(11):1771-85. doi: 10.1093/annonc/mdp261. Epub 2009 Jul 16.

  PMID: 19608616 RESULT

• Cazzaniga M, Pronzato P, Leto di Priolo SL, De Matteis A, Di Costanzo F, Passalacqua R, Rosso R, Torri V. Patterns of relapse and modalities of treatment of breast cancer: the 'IRIS' Project, a multicenter observational study. Oncology. 2004;66(4):260-8. doi: 10.1159/000078325.

  PMID: 15218292 RESULT

• Newcombe RG. Two-sided confidence intervals for the single proportion: comparison of seven methods. Stat Med. 1998 Apr 30;17(8):857-72. doi: 10.1002/(sici)1097-0258(19980430)17:83.0.co;2-e.

  PMID: 9595616 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Histologic samples for the evaluation of metastatic breast cancer according to biological subtype definition (Luminal A, Luminal B, HER2 positive, triple-negative).

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marina Cazzaniga, MD

  Azienda Ospedaliera San Gerardo-Oncologia Medica (Saint Gerard Hospital-Medical Oncology)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MD

CONTACT

Elena Abrami, MD

CONTACT

089301545; elena.abrami@cr-technology.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2014
• First Posted: February 19, 2015
• Study Start: May 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: June 15, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)