Study of Impact of Routine "Clinical Cancer Department/Supportive Care Department" Consultation on the Prescription of an Additional Line of Chemotherapy

A study testing Action Group in people with Metastatic Breast Cancer, run by Centre Leon Berard at 3 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to assess the impact of systematic "clinical cancer department/supportive care department" consultation meetings, versus standard care, on the prescription of an additional line of chemotherapy in patients with metastatic breast cancer and visceral involvement after 3 or 4 lines of… Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Metastatic Breast Cancer
What is being tested?: Action Group
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 3 sitesFrance
Study dates: Nov 2008to Jun 2014
Phase: Interventional
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
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Woman aged >= 18 years
Metastatic breast cancer with visceral involvement
Patient requiring a 3rd or a 4th line of chemotherapy
Patient followed at Léon Bérard Cancer Center
Patient affiliated with social security
Patient able to read and write French
Written, voluntary, informed consent

Who cannot join

Ongoing chemotherapy other than third or fourth line
Only skin or bone metastasis
Follow-up impossible for social, geographical, familial or psychological reasons
Patient deprived of freedom
Pregnant or lactating woman

Trial locations and contacts

3 sites in 1 country.

France3 sites

Centre Léon Bérard
Lyon, 69008
Institut Curie
Paris, 75005
Institut Curie
Saint-Cloud, 92210

Other trials in France

About this study

Official title: Randomized Controlled Trial Assessing the Impact of Routine "Oncologist-supportive Care Team" Consultation on the Use of an Additional Line of Chemotherapy in Metastatic Breast Cancer Patients

This is a prospective paucicentric open label randomized controlled study with 2 parallel arms.

Eligible patients will be randomly assigned to either arm "Study group" or "Standard care".

The number of patients required to demonstrate a 30% reduction of the number of prescriptions for an additional line chemotherapy, assuming an alpha risk of 5% and 80% power, is 100 (50 in each arm).

Read the detailed description

The hypothesis tested is that systematic routine consultation between the supportive care team and clinical oncologists will allow more efficient utilization of supportive care by metastatic breast cancer patients, and will reduce the isolation of physicians involved in the management of these patients. Physicians will then be able to help the patients make realistic decisions for the best possible quality of life and in full accordance with their preferences.

The DISSPO (Department of Interdisciplinary Supportive Care for Cancer Patients) focuses on psycho-oncology, pain evaluation and treatment, palliative care, social service, dietary guidance and physiotherapy. Usually, visits with the DISSPO are arranged when the patients need supportive care but are not included in routine care. In this study, contacts between clinical oncologists and supportive care staff will be formalized and systematized. A specific visit called "supportive care visit" will be organized to investigate the needs of the patient so that a personalized care plan can be proposed. Moreover, a consultation between the referring oncologist and the DISSPO will be organized at least once a month.

Besides the main objective of this study (see brief summary), there are secondary objectives which are to evaluate the impact of systematic "Clinical cancer department/Supportive care department" consultation meetings versus standard care on:

the use of supportive care
symptom control
anxiety-depression levels
quality of life
patient representations (adaptation to the disease and locus of control)
patient perception of social support
patient satisfaction with the care
impact of disease on the family
satisfaction of the referring oncologist

Conditions: Metastatic Breast Cancer
Being tested: Action Group, Standard care
Keywords: Metastatic breast cancer, Supportive care, Third or fourth line of chemotherapy, Quality of life, Treatment preferences
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Action GroupOther
On inclusion, a visit will be organized between the patient and at least 2 members of the DISSPO staff. It will allow an evaluation of supportive care needs and the proposition of a personalized care plan.
Then, a consultation between the referring oncologist and the DISSPO will be organized once a month, so that the personalized care plan could be adapted if necessary.
Standard careOther
No specific intervention

Study groups in NCT00905281
Study group	Role	What they receive
Action Group	Experimental	Not described Receives: Other: Action Group
Standard care	Other	Not described Receives: Other: Standard care

What is being measured

The primary outcome is the main question the study is designed to answer.

Rate of prescriptions for a 4th or 5th line of chemotherapy
When patients progress under 3rd or 4th line of chemotherapy, rate of prescriptions for a 4th or 5th line will be collected.
Measured: At the time of progression on 3rd or 4th line of chemotherapy.

Secondary outcomes (9)

Evaluation of the number and type of DISSPO interventions
Measured: During the period of inclusion in the study: between the inclusion and the time of progression on 3rd or 4th line of chemotherapy
Self-evaluation of symptom control using the Edmonton scale
Measured: Self-administered questionnaire at inclusion, at 6 months and 12 months post-inclusion, at the end and 3 months after the end of the 3rd or 4th line of chemotherapy
Self-rating of anxiety-depression using the HADS scale
Measured: Self-administered questionnaire at inclusion, at 6 months and 12 months post-inclusion, at the end and 3 months after the end of the 3rd or 4th line of chemotherapy.
Self-evaluation of quality of life using the QLQC30 scale.
Measured: Self-administered questionnaire at inclusion, at 6 months and 12 months post-inclusion, at the end and 3 months after the end of the 3rd or 4th line of chemotherapy.
Self-evaluation of adaptation and of the locus of control using the CLCS scale.
Measured: Self-administered questionnaire at inclusion, at 6 months and 12 months post-inclusion, at the end and 3 months after the end of the 3rd or 4th line of chemotherapy.
Self-evaluation of social support using the QSSP scale
Measured: Self-administered questionnaire at inclusion, at 6 months and 12 months post-inclusion, at the end and 3 months after the end of the 3rd or 4th line of chemotherapy.
Self-evaluation of satisfaction with care using the F-PMH/PSQ MD scale
Measured: Self-administered questionnaire at inclusion, at 6 months and 12 months post-inclusion, at the end and 3 months after the end of the 3rd or 4th line of chemotherapy.
Self-evaluation of the impact of disease on family using the GHQ28 scale
Measured: Self-administered questionnaire at inclusion, at 6 months and 12 months post-inclusion, at the end and 3 months after the end of the 3rd or 4th line of chemotherapy.
Self-evaluation of satisfaction by the referring physician using the Likert scale
Measured: Self-administered questionnaire at 6 months and 12 months post-inclusion, at the end and 3 months after the end of the 3rd or 4th line of chemotherapy.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2008Jun 2014

First posted20 May 2009 (estimated)
Study startNov 2008
Primary completionJun 2014
Study completionJun 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (29)Papers the sponsor has linked to this study.
Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
More trials run by Centre Leon BerardThe 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: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00905281
Sponsor's protocol ID: OSS
Other IDs: ET 2007-037
Status last verified: Feb 2015
First submitted: 5 May 2009
Last updated: 9 Feb 2015
Results posted: No
Data monitoring committee: No

Publications

Gennari A, Conte P, Rosso R, Orlandini C, Bruzzi P. Survival of metastatic breast carcinoma patients over a 20-year period: a retrospective analysis based on individual patient data from six consecutive studies. Cancer. 2005 Oct 15;104(8):1742-50. doi: 10.1002/cncr.21359.
PubMed 16149088
Slamon DJ, Leyland-Jones B, Shak S, Fuchs H, Paton V, Bajamonde A, Fleming T, Eiermann W, Wolter J, Pegram M, Baselga J, Norton L. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 2001 Mar 15;344(11):783-92. doi: 10.1056/NEJM200103153441101.
PubMed 11248153
Giordano SH, Buzdar AU, Smith TL, Kau SW, Yang Y, Hortobagyi GN. Is breast cancer survival improving? Cancer. 2004 Jan 1;100(1):44-52. doi: 10.1002/cncr.11859.
PubMed 14692023
Banerji U, Kuciejewska A, Ashley S, Walsh G, O'Brien M, Johnston S, Smith I. Factors determining outcome after third line chemotherapy for metastatic breast cancer. Breast. 2007 Aug;16(4):359-66. doi: 10.1016/j.breast.2007.01.004. Epub 2007 May 16.
PubMed 17509879
Rha SY, Moon YH, Jeung HC, Kim YT, Sohn JH, Yang WI, Suh CO, Kim GE, Roh JK, Chung HC. Gemcitabine monotherapy as salvage chemotherapy in heavily pretreated metastatic breast cancer. Breast Cancer Res Treat. 2005 Apr;90(3):215-21. doi: 10.1007/s10549-004-2468-4.
PubMed 15830134
Dufresne A, Pivot X, Tournigand C, Facchini T, Altweegg T, Chaigneau L, De Gramont A. Impact of chemotherapy beyond the first line in patients with metastatic breast cancer. Breast Cancer Res Treat. 2008 Jan;107(2):275-9. doi: 10.1007/s10549-007-9550-7. Epub 2007 Mar 23.
PubMed 17380382
Detmar SB, Muller MJ, Schornagel JH, Wever LD, Aaronson NK. Role of health-related quality of life in palliative chemotherapy treatment decisions. J Clin Oncol. 2002 Feb 15;20(4):1056-62. doi: 10.1200/JCO.2002.20.4.1056.
PubMed 11844830
Weeks JC, Cook EF, O'Day SJ, Peterson LM, Wenger N, Reding D, Harrell FE, Kussin P, Dawson NV, Connors AF Jr, Lynn J, Phillips RS. Relationship between cancer patients' predictions of prognosis and their treatment preferences. JAMA. 1998 Jun 3;279(21):1709-14. doi: 10.1001/jama.279.21.1709.
PubMed 9624023
Slevin ML, Stubbs L, Plant HJ, Wilson P, Gregory WM, Armes PJ, Downer SM. Attitudes to chemotherapy: comparing views of patients with cancer with those of doctors, nurses, and general public. BMJ. 1990 Jun 2;300(6737):1458-60. doi: 10.1136/bmj.300.6737.1458.
PubMed 2379006
Glare P, Virik K, Jones M, Hudson M, Eychmuller S, Simes J, Christakis N. A systematic review of physicians' survival predictions in terminally ill cancer patients. BMJ. 2003 Jul 26;327(7408):195-8. doi: 10.1136/bmj.327.7408.195.
PubMed 12881260
Asola R, Huhtala H, Holli K. Intensity of diagnostic and treatment activities during the end of life of patients with advanced breast cancer. Breast Cancer Res Treat. 2006 Nov;100(1):77-82. doi: 10.1007/s10549-006-9224-x. Epub 2006 Jun 7.
PubMed 16758120
Braga S, Miranda A, Fonseca R, Passos-Coelho JL, Fernandes A, Costa JD, Moreira A. The aggressiveness of cancer care in the last three months of life: a retrospective single centre analysis. Psychooncology. 2007 Sep;16(9):863-8. doi: 10.1002/pon.1140.
PubMed 17245696
A controlled trial to improve care for seriously ill hospitalized patients. The study to understand prognoses and preferences for outcomes and risks of treatments (SUPPORT). The SUPPORT Principal Investigators. JAMA. 1995 Nov 22-29;274(20):1591-8.
PubMed 7474243
Chvetzoff G, Perol D, Devaux Y, Lancry L, Rebattu P, Magnet M, Dubost E, Bertrand M, Garcon C, Thevenet G, Gobet S, Arbiol E, Saltel P. [Prospective study on the quality of care and quality of life in advanced cancer patients treated at home or in hospital: intermediate analysis of the Trapado study]. Bull Cancer. 2006 Feb;93(2):213-21. French.
PubMed 16517418
Homsi J, Walsh D, Nelson KA, LeGrand SB, Davis M, Khawam E, Nouneh C. The impact of a palliative medicine consultation service in medical oncology. Support Care Cancer. 2002 May;10(4):337-42. doi: 10.1007/s00520-002-0341-8. Epub 2002 Feb 15.
PubMed 12029434

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma

All Metastatic Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Controlled Trial Assessing the Impact of Routine "Oncologist-supportive Care Team" Consultation on the Use of an Additional Line of Chemotherapy in Metastatic Breast Cancer Patients
ClinicalTrials.gov ID: NCT00905281
Acronym / sponsor ID: OSS
Conditions: Metastatic Breast Cancer
Keywords: Metastatic breast cancer, Supportive care, Third or fourth line of chemotherapy, Quality of life, Treatment preferences
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Centre Leon BerardUniversity, hospital or other
Study start: Nov 2008
Primary completion: Jun 2014 (actual)
Study completion: Jun 2014 (actual)
First posted: 20 May 2009 (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.

This is a prospective paucicentric open label randomized controlled study with 2 parallel arms.

Eligible patients will be randomly assigned to either arm "Study group" or "Standard care".

The number of patients required to demonstrate a 30% reduction of the number of prescriptions for an additional line chemotherapy, assuming an alpha risk of 5% and 80% power, is 100 (50 in each arm).

Detailed description

the use of supportive care
symptom control
anxiety-depression levels
quality of life
patient representations (adaptation to the disease and locus of control)
patient perception of social support
patient satisfaction with the care
impact of disease on the family
satisfaction of the referring oncologist

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Action Group	Experimental	Other: Action Group
Standard care	Other	Other: Standard care

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Woman aged >= 18 years
Metastatic breast cancer with visceral involvement
Patient requiring a 3rd or a 4th line of chemotherapy
Patient followed at Léon Bérard Cancer Center
Patient affiliated with social security

Key exclusion criteria (5 listed)

Ongoing chemotherapy other than third or fourth line
Only skin or bone metastasis
Follow-up impossible for social, geographical, familial or psychological reasons
Patient deprived of freedom
Pregnant or lactating woman

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Action GroupOn inclusion, a visit will be organized between the patient and at least 2 members of the DISSPO staff. It will allow an evaluation of supportive care needs and the proposition of a personalized care plan. Then, a consultation between the referring oncologist and the DISSPO will be organized once a month, so that the personalized care plan could be adapted if necessary.	Other	Action Group
Standard careNo specific intervention	Other	Standard care

Primary outcome

Rate of prescriptions for a 4th or 5th line of chemotherapy
Time frame: At the time of progression on 3rd or 4th line of chemotherapy.
When patients progress under 3rd or 4th line of chemotherapy, rate of prescriptions for a 4th or 5th line will be collected.

9 secondary outcomes

Evaluation of the number and type of DISSPO interventions
Time frame: During the period of inclusion in the study: between the inclusion and the time of progression on 3rd or 4th line of chemotherapy
Self-evaluation of symptom control using the Edmonton scale
Time frame: Self-administered questionnaire at inclusion, at 6 months and 12 months post-inclusion, at the end and 3 months after the end of the 3rd or 4th line of chemotherapy
Self-rating of anxiety-depression using the HADS scale
Time frame: Self-administered questionnaire at inclusion, at 6 months and 12 months post-inclusion, at the end and 3 months after the end of the 3rd or 4th line of chemotherapy.
Self-evaluation of quality of life using the QLQC30 scale.
Time frame: Self-administered questionnaire at inclusion, at 6 months and 12 months post-inclusion, at the end and 3 months after the end of the 3rd or 4th line of chemotherapy.
Self-evaluation of adaptation and of the locus of control using the CLCS scale.
Time frame: Self-administered questionnaire at inclusion, at 6 months and 12 months post-inclusion, at the end and 3 months after the end of the 3rd or 4th line of chemotherapy.
Self-evaluation of social support using the QSSP scale
Time frame: Self-administered questionnaire at inclusion, at 6 months and 12 months post-inclusion, at the end and 3 months after the end of the 3rd or 4th line of chemotherapy.
Self-evaluation of satisfaction with care using the F-PMH/PSQ MD scale
Time frame: Self-administered questionnaire at inclusion, at 6 months and 12 months post-inclusion, at the end and 3 months after the end of the 3rd or 4th line of chemotherapy.
Self-evaluation of the impact of disease on family using the GHQ28 scale
Time frame: Self-administered questionnaire at inclusion, at 6 months and 12 months post-inclusion, at the end and 3 months after the end of the 3rd or 4th line of chemotherapy.
Self-evaluation of satisfaction by the referring physician using the Likert scale
Time frame: Self-administered questionnaire at 6 months and 12 months post-inclusion, at the end and 3 months after the end of the 3rd or 4th line of chemotherapy.

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 9 Feb 2015.
Background: PubMed 16149088Gennari A, Conte P, Rosso R, Orlandini C, Bruzzi P. Survival of metastatic breast carcinoma patients over a 20-year period: a retrospective analysis based on individual patient data from six consecutive studies. Cancer. 2005 Oct 15;104(8):1742-50. doi: 10.1002/cncr.21359.
Background: PubMed 11248153Slamon DJ, Leyland-Jones B, Shak S, Fuchs H, Paton V, Bajamonde A, Fleming T, Eiermann W, Wolter J, Pegram M, Baselga J, Norton L. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 2001 Mar 15;344(11):783-92. doi: 10.1056/NEJM200103153441101.
Background: PubMed 14692023Giordano SH, Buzdar AU, Smith TL, Kau SW, Yang Y, Hortobagyi GN. Is breast cancer survival improving? Cancer. 2004 Jan 1;100(1):44-52. doi: 10.1002/cncr.11859.
Background: PubMed 17509879Banerji U, Kuciejewska A, Ashley S, Walsh G, O'Brien M, Johnston S, Smith I. Factors determining outcome after third line chemotherapy for metastatic breast cancer. Breast. 2007 Aug;16(4):359-66. doi: 10.1016/j.breast.2007.01.004. Epub 2007 May 16.
Background: PubMed 15830134Rha SY, Moon YH, Jeung HC, Kim YT, Sohn JH, Yang WI, Suh CO, Kim GE, Roh JK, Chung HC. Gemcitabine monotherapy as salvage chemotherapy in heavily pretreated metastatic breast cancer. Breast Cancer Res Treat. 2005 Apr;90(3):215-21. doi: 10.1007/s10549-004-2468-4.
Background: PubMed 17380382Dufresne A, Pivot X, Tournigand C, Facchini T, Altweegg T, Chaigneau L, De Gramont A. Impact of chemotherapy beyond the first line in patients with metastatic breast cancer. Breast Cancer Res Treat. 2008 Jan;107(2):275-9. doi: 10.1007/s10549-007-9550-7. Epub 2007 Mar 23.
Background: PubMed 11844830Detmar SB, Muller MJ, Schornagel JH, Wever LD, Aaronson NK. Role of health-related quality of life in palliative chemotherapy treatment decisions. J Clin Oncol. 2002 Feb 15;20(4):1056-62. doi: 10.1200/JCO.2002.20.4.1056.
Background: PubMed 9624023Weeks JC, Cook EF, O'Day SJ, Peterson LM, Wenger N, Reding D, Harrell FE, Kussin P, Dawson NV, Connors AF Jr, Lynn J, Phillips RS. Relationship between cancer patients' predictions of prognosis and their treatment preferences. JAMA. 1998 Jun 3;279(21):1709-14. doi: 10.1001/jama.279.21.1709.
Background: PubMed 2379006Slevin ML, Stubbs L, Plant HJ, Wilson P, Gregory WM, Armes PJ, Downer SM. Attitudes to chemotherapy: comparing views of patients with cancer with those of doctors, nurses, and general public. BMJ. 1990 Jun 2;300(6737):1458-60. doi: 10.1136/bmj.300.6737.1458.
Background: PubMed 12881260Glare P, Virik K, Jones M, Hudson M, Eychmuller S, Simes J, Christakis N. A systematic review of physicians' survival predictions in terminally ill cancer patients. BMJ. 2003 Jul 26;327(7408):195-8. doi: 10.1136/bmj.327.7408.195.
Background: PubMed 16758120Asola R, Huhtala H, Holli K. Intensity of diagnostic and treatment activities during the end of life of patients with advanced breast cancer. Breast Cancer Res Treat. 2006 Nov;100(1):77-82. doi: 10.1007/s10549-006-9224-x. Epub 2006 Jun 7.
Background: PubMed 17245696Braga S, Miranda A, Fonseca R, Passos-Coelho JL, Fernandes A, Costa JD, Moreira A. The aggressiveness of cancer care in the last three months of life: a retrospective single centre analysis. Psychooncology. 2007 Sep;16(9):863-8. doi: 10.1002/pon.1140.

Related trials for Metastatic Breast Cancer

RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma

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.

CHVETZOFF Gisèle, MD principal investigator

Centre Leon Berard

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Action Group in people with Metastatic Breast Cancer, run by Centre Leon Berard at 3 sites in France.

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 7 inclusion and 5 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 9 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. 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?

Rate of prescriptions for a 4th or 5th line of chemotherapy (time frame: At the time of progression on 3rd or 4th line of chemotherapy.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00905281, which also lists 29 linked publications.

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 9 Feb 2015.