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

NCT02284581 | Unknown DMC

• 1 other identifier: GIM14-BIOMETA
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 35

Brief 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) .

Conditions

Metastatic Breast Cancer

Keywords

MBC; metastatic; breast; observational; disease management

Outcome Measures

Primary Outcomes (1)

• Duration and number of lines' treatment

  Retrospectively from 2000 up to site activation; prospectively assested up to 32 months

Secondary Outcomes (4)

• Overall Survival according duration

  Retrospectively from 2000 up to site activation; prospectively assested up to 32 months

• Overall survival according number of lines

  Retrospectively from 2000 up to site activation; prospectively assested up to 32 months

• Predictive factors of number of lines

  Retrospectively from 2000 up to site activation; prospectively assested up to 32 months

• Treatment management

  Retrospectively from 2000 up to site activation; prospectively assested up to 32 months

Other Outcomes (4)

• Impact of first line CDk4/6 inhibitors on HR+/HER2-mBC patients' financial toxicity

  30 months

• 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

• 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

Study Arms (2)

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 1st 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.

Eligibility Criteria

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

Study Population

Italian patients with metastatic breast cancer

You may qualify if:

• 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

You may not qualify if:

• Not consecutive metastatic breast cancer patients grouped for a particular biological type (for example: all HER2 positive patients).

Sponsors & Collaborators

• Consorzio Oncotech: lead

Study Sites (35)

Centro di Riferimento Oncologico

Aviano, 33081, Italy

RECRUITING

A.O. Consorziale Policlinico di Bari

Bari, 70124, Italy

RECRUITING

A.O.U. Cagliari

Cagliari, 09122, Italy

RECRUITING

Fondazione del Piemonte per l'Oncologia - I.R.C.C.

Candiolo, 10060, Italy

RECRUITING

Azienda Ospedaliera Ospedale Sant'Anna

Como, 22020, Italy

RECRUITING

Azienda Ospedaliera S. Croce e Carle

Cuneo, 12100, Italy

RECRUITING

A.O.U. Sant'Anna

Ferrara, 44124, Italy

RECRUITING

Ospedale 'F. Spaziani'

Frosinone, 03100, Italy

NOT YET RECRUITING

Ospedale Policlinico San Martino IRCCS

Genova, 16132, Italy

RECRUITING

A.O. Ospedale Civile di Legnano

Legnano, 20025, Italy

RECRUITING

IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l.

Meldola, 47014, Italy

NOT YET RECRUITING

ASST Fatebenefratelli Sacco - P.O. Fatebenefratelli

Milan, 20121, Italy

RECRUITING

Ospedale Maggiore Policlinico - Fondazione IRCCS Ca' Granda

Milan, 20122, Italy

NOT YET RECRUITING

A.O.R.N. "A. Cardarelli"

Napoli, 80131, Italy

RECRUITING

Azienda ospedaliero universitaria "Federico II"

Napoli, 80131, Italy

RECRUITING

Istituto Nazionale per lo studio dei Tumori - Fondazione 'Pascale'

Napoli, 80131, Italy

RECRUITING

Azienda Ospedaliero-Universitaria di Parma

Parma, 43126, Italy

NOT YET RECRUITING

Fondazione Maugeri IRCCS

Pavia, 27100, Italy

RECRUITING

A.O.U. Pisana

Pisa, 56126, Italy

RECRUITING

IRCCS Arcispedale Santa Maria Nuova

Reggio Emilia, 42123, Italy

NOT YET RECRUITING

Istituto Regina Elena per lo studio e la cura dei tumori

Roma, 00144, Italy

RECRUITING

Policlinico Universitario A. Gemelli- DH Radiochemioterapia

Roma, 00168, Italy

RECRUITING

Policlinico Universitario Agostino Gemelli, IRCSS-Unità Medicina di Precisione in Senologia

Roma, 00168, Italy

RECRUITING

Policlinico Umberto I Università "La Sapienza" di Roma

Roma, 00185, Italy

RECRUITING

Azienda Ospedaliera S. Andrea

Roma, 00189, Italy

NOT YET RECRUITING

Ospedale Sandro Pertini

Roma, 00189, Italy

RECRUITING

Asl Roma 1 - Ospedale Santo Spirito

Roma, 00193, Italy

RECRUITING

Istituto Clinico Humanitas

Rozzano, 20089, Italy

RECRUITING

Azienda Ospedaliera S. Andrea

Sassari, 07100, Italy

NOT YET RECRUITING

Ospedale Civile SS. Annunziata

Sassari, 07100, Italy

RECRUITING

Ospedale 'SS. Trinità'

Sora, 03039, Italy

NOT YET RECRUITING

A.O.U. Città della Salute e della Scienza di Torino - Presidio San Lazzaro

Torino, 10126, Italy

NOT YET RECRUITING

P.O. Martini - ASL TO1

Torino, 10141, Italy

RECRUITING

ASL Alessandria - Ospedale Civile Santi Antonio e Margherita

Tortona, 15057, Italy

RECRUITING

A.O.U. Santa Maria della Misericordia di Udine

Udine, 33100, Italy

RECRUITING

Related Publications (5)

• 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.

  PMID: 20555067 BACKGROUND

• 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.

  PMID: 22493340 BACKGROUND

• 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.

  PMID: 24453294 BACKGROUND

• 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.

  PMID: 21709140 BACKGROUND

• Conte 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 DERIVED

Biospecimen

Retention: NONE RETAINED

Evaluation of duration of metastatic breast cancer treatments and numer of lines according to biological subtype (Luminal A, Luminal B, HER2 positive, triple-negative)

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

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

Study Officials

• Claudia Bighin, MD

  IRCCS- Azienda Ospedaliera Universitaria San Martino-IST

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudia Bighin, MD

CONTACT

0105600898; claudia.bighin@hsanmartino.it

Eva Blondeaux, MD

CONTACT

eva.blondeaux@hsanmartino.it

Study Design

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

Study Record Dates

• First Submitted: September 10, 2014
• First Posted: November 6, 2014
• Study Start: November 1, 2015
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2025
• Last Updated: November 13, 2023

Record last verified: 2023-11

Locations

IT (35)