Breast NeoplasmsPhase 2NCT01298713
Tamoxifen-RAD001 Versus Tamoxifen Alone in Patients With Anti-aromatase Resistant Breast Metastatic Cancer
A Phase 2 study testing Tamoxifen and Everolimus in people with Breast Neoplasms and mTor Protein, run by ARCAGY/ GINECO GROUP at 1 site in France.
Trial summary
Tamoxifen is a classical treatment for breast metastatic cancer after 3rd generation anti-aromatase hormonotherapy in adjuvant or in metastatic line. The Tamoxifen efficacy is lowered by the hormonoresistance mechanisms due to the primary use of the anti-aromatases. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms, mTor Protein
- What is being tested?
- Tamoxifen and Everolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2008to 12 Sep 2018
- Phase
- Phase 2
- 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
- Menopausal female patient aged > 18 years
- Histologically proven breast adenocarcinoma
- ER and/or PR positive receptors and HER2 negative
- previously received first or second line of hormonotherapy for metastatic disease
- previously treated with anti-aromatase in adjuvant and/or in metastatic line
- presence of one or several mesurable or evaluable metastatic lesion(s)
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- presence of at least one target lesion not previously irradiated
- ECOG Performance status < 2
- adequate biological values
- patient who has clearly given her consent by signing on informed consent form prior to participation
Who cannot join
- patient with only local metastatic disease that can be treted by surgery
- uncotrolled brain metastases, pulmonary carcinomatosal lymphangitis, hepatic metastases
- Previous treatment by Tamoxifen unless in adjuvant and terminated more than a year before metastatic relapse
- Patient with a tumor surexpressing HER2 that should be treated by trastuzumab
- Patient that need an immediate local antalgic radiotherapy
- Thrombo-embolism disease
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- serious concomitant pathology or uncontrolled that is susceptible to compromise the participation in the study
- history of another malignancy within past 5 years that could confound diagnosis or staging of breast cancer (with the exception of in situ cacinoma of the cervix or adequately treated basel cell carcinoma of the skin) and cancers cured for at least for 5 years
- patient with an history of significant cardiovascular impairment (congestive heart failure> NYHA grade II, unstable angina or myocardial infraction within the past six months or serious cardiac arrhythmia)
- patient with any medical or psychiatric condition that, in the opinion of the Principal Investigator, would preclude her from participating in this study
- patient with a known allergy to one or several of the study compounds
- patients who may not be regularly available due to geographical, social or family reasons
- history of renal, hepatic or metabolic pathology that could preclude with metabolism or elimination of the study product
- deficiencies of the upper intestinal tract, malabsorption syndrome
- patient who is pregnant, breast-feeding or using inadequate contraception
- Treatment with experimental drugs (mTor inhibitor or tyrosin kinase inhibitor)
- Patient treated with molecules that interfer with isoenzyme CYP3A
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Study Assessing the Tolerance and Efficacy of Tamoxifen Alone Versus the Association Tamoxifen-RAD001 (Everolimus) in Patients With Anti-aromatase Resistant Breast Metastatic Cancer
Tamoxifen is a classical treatment for breast metastatic cancer after 3rd generation anti-aromatase hormonotherapy in adjuvant or in metastatic line. The Tamoxifen efficacy is lowered by the hormonoresistance mechanisms due to the primary use of the anti-aromatases. The Pi3K-AKT-mTor pathway is frequently associated to the hormonoresistance mechanisms. This study is aimed to check if the inhibition of this signal transduction pathway by a synthetic mTor inhibitor (Everolimus) could improve the efficacy of the Tamoxifen.
- Conditions
- Breast Neoplasms, mTor Protein
- Being tested
- Tamoxifen, Everolimus
- Keywords
- Hormonoresistance, tamoxifen, Previously received anti-aromatase treatment, mTor inhibitor
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamoxifenDrug
20mg daily (1 cap) until unbearable toxicity or progression
EverolimusDrug
Also called RAD001
10mg daily (2 caps of 5mg) until unbearable toxicity or progression
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Tamoxifen 20mg/d Receives: Drug: Tamoxifen |
| B | Experimental | Tamoxifen 20mg/d + RAD001 10mg/d Receives: Drug: Tamoxifen; Drug: Everolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical benefit at 24 weeks
Measured: 42 months
Secondary outcomes (3)
Partial and complete response per RECIST
Measured: 42 months
Qualitative and quantitative toxicities
Measured: 24 months
Overall survival
Measured: 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startMar 2008
- Primary completionJun 2011
- Study completion12 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARCAGY/ GINECO GROUP
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01298713
- Sponsor's protocol ID
- TAMRAD
- Other IDs
- EUDRACT 2006-004332-79
- Status last verified
- Sep 2023
- First submitted
- 16 Feb 2011
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Treilleux I, Arnedos M, Cropet C, Wang Q, Ferrero JM, Abadie-Lacourtoisie S, Levy C, Legouffe E, Lortholary A, Pujade-Lauraine E, Bourcier AV, Eymard JC, Spaeth D, Bachelot T. Translational studies within the TAMRAD randomized GINECO trial: evidence for mTORC1 activation marker as a predictive factor for everolimus efficacy in advanced breast cancer. Ann Oncol. 2015 Jan;26(1):120-125. doi: 10.1093/annonc/mdu497. Epub 2014 Oct 31.
PubMed 25361980
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study Assessing the Tolerance and Efficacy of Tamoxifen Alone Versus the Association Tamoxifen-RAD001 (Everolimus) in Patients With Anti-aromatase Resistant Breast Metastatic Cancer
- ClinicalTrials.gov ID
- NCT01298713
- Acronym / sponsor ID
- TAMRAD
- Conditions
- Breast Neoplasms, mTor Protein
- Keywords
- Hormonoresistance, tamoxifen, Previously received anti-aromatase treatment, mTor inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- ARCAGY/ GINECO GROUPUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Mar 2008 (actual)
- Primary completion
- Jun 2011 (actual)
- Study completion
- 12 Sep 2018 (actual)
- First posted
- 18 Feb 2011 (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.
Tamoxifen is a classical treatment for breast metastatic cancer after 3rd generation anti-aromatase hormonotherapy in adjuvant or in metastatic line. The Tamoxifen efficacy is lowered by the hormonoresistance mechanisms due to the primary use of the anti-aromatases. The Pi3K-AKT-mTor pathway is frequently associated to the hormonoresistance mechanisms. This study is aimed to check if the inhibition of this signal transduction pathway by a synthetic mTor inhibitor (Everolimus) could improve the efficacy of the Tamoxifen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: TamoxifenTamoxifen 20mg/d |
| B | Experimental | Drug: Tamoxifen, Drug: EverolimusTamoxifen 20mg/d + RAD001 10mg/d |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Menopausal female patient aged > 18 years
- Histologically proven breast adenocarcinoma
- ER and/or PR positive receptors and HER2 negative
- previously received first or second line of hormonotherapy for metastatic disease
- previously treated with anti-aromatase in adjuvant and/or in metastatic line
Key exclusion criteria (17 listed)
- patient with only local metastatic disease that can be treted by surgery
- uncotrolled brain metastases, pulmonary carcinomatosal lymphangitis, hepatic metastases
- Previous treatment by Tamoxifen unless in adjuvant and terminated more than a year before metastatic relapse
- Patient with a tumor surexpressing HER2 that should be treated by trastuzumab
- Patient that need an immediate local antalgic radiotherapy
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 |
|---|---|---|
| Tamoxifen20mg daily (1 cap) until unbearable toxicity or progression | Drug | A, B |
| EverolimusAlso: RAD00110mg daily (2 caps of 5mg) until unbearable toxicity or progression | Drug | B |
Primary outcome
Clinical benefit at 24 weeks
Time frame: 42 months
3 secondary outcomes
Partial and complete response per RECIST
Time frame: 42 months
Qualitative and quantitative toxicities
Time frame: 24 months
Overall survival
Time frame: 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 6 Sep 2023.
- Derived from this study: PubMed 25361980Treilleux I, Arnedos M, Cropet C, Wang Q, Ferrero JM, Abadie-Lacourtoisie S, Levy C, Legouffe E, Lortholary A, Pujade-Lauraine E, Bourcier AV, Eymard JC, Spaeth D, Bachelot T. Translational studies within the TAMRAD randomized GINECO trial: evidence for mTORC1 activation marker as a predictive factor for everolimus efficacy in advanced breast cancer. Ann Oncol. 2015 Jan;26(1):120-125. doi: 10.1093/annonc/mdu497. Epub 2014 Oct 31.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tamoxifen and Everolimus in people with Breast Neoplasms and mTor Protein, run by ARCAGY/ GINECO GROUP at 1 site 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 10 inclusion and 17 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 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Clinical benefit at 24 weeks (time frame: 42 months). 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 NCT01298713, which also lists 1 linked publication.
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 6 Sep 2023.