Evaluation of Medical Treatments in MBC Patients According Biological Subtype and Line of Treatments

Metastatic Breast Cancer Clinical Trial

— BIO-META  

Official title:

Evaluation of Medical Treatments (Chemotherapy, Hormonal Therapy and Biological Therapies) in Metastatic Breast Cancer Patients According to Biologic Subtype and Line of Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02284581
• Other study ID #: GIM14-BIOMETA
• Status: Recruiting
• Start date: November 2015
• Est. completion date: December 2025

Study information

• Verified date: November 2023
• Source: Consorzio Oncotech
• Contact: Claudia Bighin, MD
• Phone: 0105600898
• Email: claudia.bighin[@]hsanmartino.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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) .

Description:

The primary objectives are to evaluate the duration of metastatic breast cancer treatments (chemotherapy, hormonal therapy and biological therapies) according to biological subtype (Luminal A, Luminal B, HER2 positive, triple-negative) and to evaluate the number of lines of metastatic breast cancer treatments according to biological subtype (Luminal A, Luminal B, HER2 positive, triple-negative).

The secondary Objectives are to evaluate overall survival according to duration and to number of lines of metastatic breast cancer treatments and to identify predictive factors of number of lines of treatment as for example age, treatment response, biological subtype, metastatic sites, etc and to identify possible elements of different treatment management between participating sites.

The aim of this retrospective and prospective study is to identify the duration of treatments (chemotherapy, hormonal therapy and biological therapies) according to biological subtype and line of treatment in metastatic breast cancer patients.

An ancillary study will be conducted on part of population (HR+/HER2- patients newly diagnosed for mBC receiving first line CDk4/6 inhibitors).

For the ancillary study, it is expected to enroll at least 400 patients, who will be asked to fill in some questionnaires at the following visits, scheduled as per clinical practice:

• PROFFIT: baseline, day 1 cycle 3, day 1 cycle 5, every 6 months thereafter;

• Patient-reported outcomes (PRO): EORTC-QLQ-C30, FACT-B, COST-FACIT at baseline, day 1 cycle 3, day 1 cycle 5, every 6 months thereafter.

The ancillary study could evaluate:

• the impact of first line CDk4/6 inhibitors on HR+/HER2- metastatic breast cancer patients' financial toxicity

• retrospectively, the correlation between NLR and outcome in patients with breast cancer and in treatment with a CDk4/6 Inhibitor (as first line vs as second line)

• the correlation between BMI and outcome in patients with breast cancer and in treatment with a CDk4/6 Inhibitor (as first line vs as second line).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 2025
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Locations

Country	Name	City	State
Italy	Centro di Riferimento Oncologico	Aviano
Italy	A.O. Consorziale Policlinico di Bari	Bari
Italy	A.O.U. Cagliari	Cagliari
Italy	Fondazione del Piemonte per l'Oncologia - I.R.C.C.	Candiolo
Italy	Azienda Ospedaliera Ospedale Sant'Anna	Como
Italy	Azienda Ospedaliera S. Croce e Carle	Cuneo
Italy	A.O.U. Sant'Anna	Ferrara
Italy	Ospedale 'F. Spaziani'	Frosinone
Italy	Ospedale Policlinico San Martino IRCCS	Genova
Italy	A.O. Ospedale Civile di Legnano	Legnano
Italy	IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l.	Meldola
Italy	ASST Fatebenefratelli Sacco - P.O. Fatebenefratelli	Milano
Italy	Ospedale Maggiore Policlinico - Fondazione IRCCS Ca' Granda	Milano
Italy	A.O.R.N. "A. Cardarelli"	Napoli
Italy	Azienda ospedaliero universitaria "Federico II"	Napoli
Italy	Istituto Nazionale per lo studio dei Tumori - Fondazione 'Pascale'	Napoli
Italy	Azienda Ospedaliero-Universitaria di Parma	Parma
Italy	Fondazione Maugeri IRCCS	Pavia
Italy	A.O.U. Pisana	Pisa
Italy	IRCCS Arcispedale Santa Maria Nuova	Reggio Emilia
Italy	Asl Roma 1 - Ospedale Santo Spirito	Roma
Italy	Azienda Ospedaliera S. Andrea	Roma
Italy	Istituto Regina Elena per lo studio e la cura dei tumori	Roma
Italy	Ospedale Sandro Pertini	Roma
Italy	Policlinico Umberto I Università "La Sapienza" di Roma	Roma
Italy	Policlinico Universitario A. Gemelli- DH Radiochemioterapia	Roma
Italy	Policlinico Universitario Agostino Gemelli, IRCSS-Unità Medicina di Precisione in Senologia	Roma
Italy	Istituto Clinico Humanitas	Rozzano
Italy	Azienda Ospedaliera S. Andrea	Sassari
Italy	Ospedale Civile SS. Annunziata	Sassari
Italy	Ospedale 'SS. Trinità'	Sora
Italy	A.O.U. Città della Salute e della Scienza di Torino - Presidio San Lazzaro	Torino
Italy	P.O. Martini - ASL TO1	Torino
Italy	ASL Alessandria - Ospedale Civile Santi Antonio e Margherita	Tortona
Italy	A.O.U. Santa Maria della Misericordia di Udine	Udine

Sponsors (1)

Lead Sponsor	Collaborator
Consorzio Oncotech

Country where clinical trial is conducted

Italy, 

References & Publications (4)

Cardoso 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. — View Citation

Goldhirsch 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. — View Citation

Schnipper 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. — View Citation

Seah 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Impact of first line CDk4/6 inhibitors on HR+/HER2-mBC patients' financial toxicity		30 months
Other	Correlation between NLR and outcome in patients with breast cancer and in treatment with a CDk4/6 Inhibitor (as first line vs as second line)		30 months
Other	Correlation between BMI and outcome in patients with breast cancer and in treatment with a CDk4/6 Inhibitor (as first line vs as second line)		30 months
Other	Differences to the previously cited outcomes according to the type of CDk4/6 inhibitors		30 months
Primary	Duration and number of lines' treatment		Retrospectively from 2000 up to site activation; prospectively assested up to 32 months
Secondary	Overall Survival according duration		Retrospectively from 2000 up to site activation; prospectively assested up to 32 months
Secondary	Overall survival according number of lines		Retrospectively from 2000 up to site activation; prospectively assested up to 32 months
Secondary	Predictive factors of number of lines		Retrospectively from 2000 up to site activation; prospectively assested up to 32 months
Secondary	Treatment management		Retrospectively from 2000 up to site activation; prospectively assested up to 32 months