Observation of Medical Treatments in MBC HER2-negative Patients

Metastatic Breast Cancer Clinical Trial

— AMBRA  

Official title:

Evaluation of Medical Treatments in MBC HER2 Negative Patients in Italy - Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02365831
• Other study ID #: GIM13-AMBRA
• Status: Recruiting
• Phase: N/A
• First received: December 15, 2014
• Last updated: June 14, 2016
• Start date: May 2015
• Est. completion date: December 2017

Study information

• Verified date: June 2016
• Source: Consorzio Oncotech
• Contact: , MD
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial 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. 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.

Description:

In particular, the attention will be on those factors, largely discussed in the literature, that predominantly guide the choice among different therapeutic approaches such as:

• metastatic sites;

• hormone receptor status;

• disease-free interval;

• grading;

• response to a previous treatment with hormonal therapy or chemotherapy. The primary objective is the description of medical therapeutic strategies for the first, the second and the subsequent lines of chemotherapy in a cohort of patients with HER2-negative metastatic breast cancer and the evaluation of the possible correlation between the choice of treatment, in the adjuvant phase or for the metastatic disease and also for the patients' characteristics (age, menopausal status, comorbidity).

the secondary objectives are:

• Analyze the "Time to Treatment Change", defined as the interval of time that elapses from the start of chemotherapy to the discontinuation or the occurrence of any other event. This finding is of a particular clinical relevance, since randomized trials using the "Time To Progression" (TTP) as a measure of effectiveness of the treatment in the study, but this time parameter may not correspond to what is observed in clinical practice, where the revaluations of disease are not conducted at preset intervals as is in the case of controlled clinical trials.

• Evaluate the correlation between the characteristics of the patients and the choice of the type of chemotherapy.

• Assess the potential correlation between the type of adjuvant therapy and the type of response obtained with the first-line treatment and between the answer to this last therapy line and second/third one.

• Assess the adherence to the literature's recommendations (Consensus Conferences and Guide-lines) of the choices between the sequential therapy vs the combination therapy in different lines of treatment (first, second, third line) of the metastatic disease.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Metastatic Breast Cancer

Intervention

Other:
• Observation of treatment management
Group/cohort

Locations

Country	Name	City	State
Italy	A.O. San Gerardo	Monza

Sponsors (2)

Lead Sponsor	Collaborator
Consorzio Oncotech	Clinical Research Technology

Country where clinical trial is conducted

Italy, 

References & Publications (14)

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 — View Citation

Beslija S, Bonneterre J, Burstein HJ, Cocquyt V, Gnant M, Heinemann V, Jassem J, Köstler 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 — View Citation

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. — View Citation

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. Epub 2006 Jun 21. — View Citation

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 — View Citation

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 — View Citation

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, Prit — View Citation

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. — View Citation

Newcombe RG. Two-sided confidence intervals for the single proportion: comparison of seven methods. Stat Med. 1998 Apr 30;17(8):857-72. — View Citation

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. — View Citation

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. — View Citation

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, Láng I, Nitz U, Iwata H, Thomssen C, Lohris — View Citation

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 Cance — View Citation

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, Sánchez 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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Time to Treatment Change	evaluation of the time interval between the begin of chemotherapic treatment and its interruption.	Outcome 2 assessed up to 24 months (2012 until 2016 where applicable)	No
Secondary	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)	No
Secondary	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)	No