DD-CMM: Quality of Life in Metastatic Breast Cancer (MBC) Patients in Second Line Monochemotherapy

Sponsor

Celgene (Industry)

Overall Status

Completed

CT.gov ID

NCT02403869

Collaborator

(none)

149

Enrollment

Locations

58.7

Actual Duration (Months)

5.1

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Post-authorization, prospective follow-up, multi-centre, national study to estimate definitive deterioration in the quality of life in patients with metastatic breast cancer treated with second-line monochemotherapy.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasms

Detailed Description

Post-authorization, prospective, multi-centre study in Metastatic Breast Cancer patients treated with second-line monochemotherapy.

A total of 200 patients are expected to be recruited from 32 Spanish sites.

In this study the results perceived by patients will be compiled to assess overall Quality of Life (QoL) in MBC patients treated with second-line monochemotherapy, using the EORTC QLQ-C30 questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire) and its modules EORTC QLQ-BR23 (EORTC Breast Cancer specific) and EORTC QLQ-CIPN20 (EORTC Chemotherapy-Induced Peripheral Neuropathy).

Patients will be evaluated at the time of acceptance to participate in the study after signing the informed consent and will be tracked every three months during treatment with second-line monochemotherapy, coinciding with routine assessments within normal clinical practice. When the patient completes treatment with second-line chemotherapy he/she will enter the post-treatment period, with follow-up at six and 12 months after completion of treatment. Also, patients will be followed to assess survival until the end of the study (30 months after enrolment of the last patient in the study). Follow-up time has been established based on the median survival of patients with MBC

Study Design

Study Type:

Observational

Actual Enrollment :

149 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Study of Quality of Life in Patients With Metastatic Breast Cancer Treated With Second-line Monochemotherapy

Actual Study Start Date :

Mar 12, 2014

Actual Primary Completion Date :

Jan 31, 2019

Actual Study Completion Date :

Jan 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Group 1 MBC patients starting treatment with monochemotherapy for second line of quimiotherapy treatment for metastatic disease

Outcome Measures

Primary Outcome Measures

Definitive deterioration at 6 months [6 months]
Proportion of patients with definitive deterioration at six months after initiation of second-line mono-chemotherapy for MBC

Secondary Outcome Measures

Definitive deterioration at 3 months [3 Months]
Description Proportion of patients with definitive deterioration at 3 months after the start of the second-line mono-chemotherapy and at the time of disease progression or completion of treatment for other reasons
Definitive deterioration at 9 months [9 Months]
Proportion of patients with definitive deterioration at 9 months after the start of the second-line mono-chemotherapy and at the time of disease progression or completion of treatment for other reasons
Definitive deterioration at 12 months [12 Months]
Proportion of patients with definitive deterioration at 12 months after the start of the second-line mono-chemotherapy and at the time of disease progression or completion of treatment for other reasons
Time to Definitive deterioration (TTDD) [Up to 42 months]
Estimated median TTDD using the actuarial method
Overall survival [Up to 42 months]
Estimated overall survival using the Kaplan-Meier method
TTDD as a prognostic factor [Up to 42 months]
Determine if TTDD is an independent prognostic factor for overall survival using Cox regression.
Quality of life [Up to 42 months]
Comparison of the mean score of the scales of the EORTC QLQ-C30, EORTC QLQ-BR23 and between patients ≥70 years and <70 years at baseline, every 3 months approximately and at the time of disease progression or completion of treatment for other reasons
Quality of life every 3 months [Up to 42 months]
Score in the scales of the EORTC QLQ-C30 and EORTC QLQ-BR23 questionnaires at baseline, every 3 months approximately and at the time of disease progression or completion of treatment for other reasons.
Chemotherapy-induced peripheral neuropathy [Up to 42 months]
Incidence, management and duration of chemotherapy-induced peripheral neuropathy at baseline, every 3 months approximately up to disease progression and at 6 and 12 months after completion of second-line chemotherapy
Chemotherapy-induced peripheral neuropathy in the EORTC QLQ-CIPN20 [Up to 42 months]
Assess the effect of chemotherapy-induced peripheral neuropathy in the EORTC QLQ-CIPN20 quality of life questionnaire at baseline, every 3 months approximately up to disease progression or completion of treatment for other reasons and at 6 and 12 months after completion of second-line chemotherapy
Definitive deterioration [Up to 42 months]
Comparison of the proportion of patients with definitive deterioration at every 3 months approximately up to disease progression or completion of treatment for other reasons in patients with ECOG 0-1 and ECOG 2-3, using the chi-squared test.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients who give their written informed consent.
Patients with metastatic breast cancer who start treatment with second-line monochemotherapy.
Patients of both sexes, at least 18 years of age and of any race.
Patients with life expectancy longer than or equal to 12 weeks.
Patients with histological or cytological diagnosis of Her-2/neu negative breast adenocarcinoma.
Patients with ability enough to understand the questionnaires.

Exclusion Criteria:

Pregnant or lactating women.
Patients who have been treated with chemotherapy in the last three weeks
Patients who refuse to participate in the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Juan Ramón Jiménez	Huelva	Andalucía	Spain	21005
2	Hospital Virgen de Valme	Sevilla	Andalucía	Spain	41013
3	Hospital Virgen del Rocío	Sevilla	Andalucía	Spain	41013
4	Hospital Miguel Servet	Zaragoza	Aragón	Spain	50009
5	Hospital Universitario Lozano Blesa	Zaragoza	Aragón	Spain	50009
6	Hospital Son Llatzer	Palma de Mallorca	Baleares	Spain	07198
7	Hospital Universitario Son Espases	Palma Mallorca	Baleares	Spain	07120
8	Hospital Universitario Canarias	La Laguna, Santa Cruz De Tenerife	Canarias	Spain	38320
9	Hospital Virgen de la Salud. Toledo	Toledo	Castilla La Mancha	Spain	45071
10	Hospital Universitario Burgos	Burgos	Castilla Y León	Spain	09005
11	Complejo Hospitalario de León	León	Castilla Y León	Spain	24001
12	Hospital Bierzo	León	Castilla Y León	Spain	24404
13	Hospital Universitario Salamanca	Salamanca	Castilla Y León	Spain	37007
14	Centro Médico Teknon	Barcelona	Cataluña	Spain	08022
15	Hospital Clinic Barcelona	Barcelona	Cataluña	Spain	08036
16	Hospital Universitario San Joan de Reus	Reus, Tarragona	Cataluña	Spain	43204
17	Corporación Sanitaria Parc Taulí- Sabadell	Sabadell	Cataluña	Spain	08208
18	Hospital Universitario Elche	Elche	Comunidad Valenciana	Spain	03203
19	Hospital Universitario y Politécnico La Fe	Valencia	Comunidad Valenciana	Spain	46026:
20	H. Infanta Cristina de Badajoz	Badajoz	Extremadura	Spain	06080
21	H. San Pedro de Alcántara	Cáceres	Extremadura	Spain	10003
22	Complejo Hospitalario de Ourense	Ourense	Galicia	Spain	32005
23	Complejo Hospitalario de Pontevedra-Montecelo	Pontevedra	Galicia	Spain	36071
24	Complejo Hospitalario Universitario de Santiago Compostela	Santiago de Compostela	Galicia	Spain	15706
25	Complejo Hospitalario de Vigo	Vigo	Galicia	Spain	36036
26	Hospital Universitario de Navarra	Pamplona	Navarra	Spain	31008
27	Hospital Universitario Gregorio Marañón	Madrid		Spain	28007
28	Hospital Universitario Ramón y Cajal	Madrid		Spain	28034
29	Hospital Infanta Sofía	Madrid		Spain	28702