Breast NeoplasmsDD-CMMNCT02403869
Quality of Life in Metastatic Breast Cancer (MBC) Patients in Second Line Monochemotherapy
An observational study of Breast Neoplasms, run by Celgene at 29 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms
- How many people
- 149 participants
- Where
- 29 sitesSpain
- Study dates
- 12 Mar 2014to 31 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: MBC patients, older than or equal to 18 years of age, on second line of treatment with chemotherapy regimens in monotherapy and Her-2/neu-negative status
Who may be able to join
- 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.
Who cannot join
- Pregnant or lactating women.
- Patients who have been treated with chemotherapy in the last three weeks
- Patients who refuse to participate in the study.
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
Spain29 sites
H. Infanta Cristina de Badajoz
Badajoz, Extremadura, 06080
Centro Médico Teknon
Barcelona, Catalonia, 08022
Hospital Clinic Barcelona
Barcelona, Catalonia, 08036
Hospital Universitario Burgos
Burgos, Castille and León, 09005
H. San Pedro de Alcántara
Cáceres, Extremadura, 10003
Hospital Universitario Elche
Elche, Valencia, 03203
Hospital Juan Ramón Jiménez
Huelva, Andalusia, 21005
Hospital Universitario Canarias
La Laguna, Santa Cruz de Tenerife, Canary Islands, 38320
Complejo Hospitalario de León
León, Castille and León, 24001
Hospital Bierzo
León, Castille and León, 24404
Hospital Universitario Gregorio Marañón
Madrid, 28007
Hospital Universitario Ramón y Cajal
Madrid, 28034
Hospital Infanta Sofía
Madrid, 28702
Complejo Hospitalario de Ourense
Ourense, Galicia, 32005
Hospital Son Llatzer
Palma de Mallorca, Balearic Islands, 07198
Hospital Universitario Son Espases
Palma Mallorca, Balearic Islands, 07120
Hospital Universitario de Navarra
Pamplona, Navarre, 31008
Complejo Hospitalario de Pontevedra-Montecelo
Pontevedra, Galicia, 36071
Hospital Universitario San Joan de Reus
Reus, Tarragona, Catalonia, 43204
Corporación Sanitaria Parc Taulí- Sabadell
Sabadell, Catalonia, 08208
Hospital Universitario Salamanca
Salamanca, Castille and León, 37007
Complejo Hospitalario Universitario de Santiago Compostela
Santiago de Compostela, Galicia, 15706
Hospital Virgen de Valme
Seville, Andalusia, 41013
Hospital Virgen del Rocío
Seville, Andalusia, 41013
Hospital Virgen de la Salud. Toledo
Toledo, Castille-La Mancha, 45071
Hospital Universitario y Politécnico La Fe
Valencia, Valencia, 46026:
Complejo Hospitalario de Vigo
Vigo, Galicia, 36036
Hospital Miguel Servet
Zaragoza, Aragon, 50009
Hospital Universitario Lozano Blesa
Zaragoza, Aragon, 50009
About this study
Official title: Study of Quality of Life in Patients With Metastatic Breast Cancer Treated With Second-line Monochemotherapy
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.
Read the 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
- Conditions
- Breast Neoplasms
- Keywords
- Metastatic breast cancer, Monotherapy, chemotherapy, second line, treatment, Her 2 negative
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | MBC patients starting treatment with monochemotherapy for second line of quimiotherapy treatment for metastatic disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Definitive deterioration at 6 months
Proportion of patients with definitive deterioration at six months after initiation of second-line mono-chemotherapy for MBC
Measured: 6 months
Secondary outcomes (11)
Definitive deterioration at 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
Measured: 3 Months
Definitive deterioration at 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
Measured: 9 Months
Definitive deterioration at 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
Measured: 12 Months
Time to Definitive deterioration (TTDD)
Estimated median TTDD using the actuarial method
Measured: Up to 42 months
Overall survival
Estimated overall survival using the Kaplan-Meier method
Measured: Up to 42 months
TTDD as a prognostic factor
Determine if TTDD is an independent prognostic factor for overall survival using Cox regression.
Measured: Up to 42 months
Quality of life
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
Measured: Up to 42 months
Quality of life every 3 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.
Measured: Up to 42 months
Chemotherapy-induced peripheral neuropathy
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
Measured: Up to 42 months
Chemotherapy-induced peripheral neuropathy in the EORTC QLQ-CIPN20
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
Measured: Up to 42 months
Definitive deterioration
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.
Measured: Up to 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study start12 Mar 2014
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02403869
- Sponsor's protocol ID
- CEL-CMM-2013-01
- Acronym
- DD-CMM
- Status last verified
- Jun 2022
- First submitted
- 19 Mar 2015
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Quality of Life in Patients With Metastatic Breast Cancer Treated With Second-line Monochemotherapy
- ClinicalTrials.gov ID
- NCT02403869
- Acronym / sponsor ID
- DD-CMM / CEL-CMM-2013-01
- Conditions
- Breast Neoplasms
- Keywords
- Metastatic breast cancer, Monotherapy, chemotherapy, second line, treatment, Her 2 negative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 12 Mar 2014 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 31 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –MBC patients starting treatment with monochemotherapy for second line of quimiotherapy treatment for metastatic disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MBC patients, older than or equal to 18 years of age, on second line of treatment with chemotherapy regimens in monotherapy and Her-2/neu-negative status
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- Pregnant or lactating women.
- Patients who have been treated with chemotherapy in the last three weeks
- Patients who refuse to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Definitive deterioration at 6 months
Time frame: 6 months
Proportion of patients with definitive deterioration at six months after initiation of second-line mono-chemotherapy for MBC
11 secondary outcomes
Definitive deterioration at 3 months
Time frame: 3 Months
Definitive deterioration at 9 months
Time frame: 9 Months
Definitive deterioration at 12 months
Time frame: 12 Months
Time to Definitive deterioration (TTDD)
Time frame: Up to 42 months
Overall survival
Time frame: Up to 42 months
TTDD as a prognostic factor
Time frame: Up to 42 months
Quality of life
Time frame: Up to 42 months
Quality of life every 3 months
Time frame: Up to 42 months
Chemotherapy-induced peripheral neuropathy
Time frame: Up to 42 months
Chemotherapy-induced peripheral neuropathy in the EORTC QLQ-CIPN20
Time frame: Up to 42 months
Definitive deterioration
Time frame: Up to 42 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms, run by Celgene at 29 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Definitive deterioration at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2022.