Breast NeoplasmsPhase 2NCT00210028
Study Assessing Efficacy of ZARNESTRA™ Combined With Tamoxifen in Patients With Advanced or Metastatic Breast Cancer
A Phase 2 study testing Tamoxifen and Zarnestra in people with Breast Neoplasms, run by Institut Claudius Regaud at 3 sites in France.
Trial summary
The purpose of this study is to evaluate the objective response rate when ZARNESTRA is added to treatment with tamoxifen Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Tamoxifen and Zarnestra
- How many people
- 40 participants
- Where
- 3 sitesFrance
- Study dates
- Aug 2003to Aug 2008
- 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
- Histologically proven, metastatic or locally advanced inoperable breast cancer
- Tumor considered potentially hormone-sensitive, i.e. presence by IHC of hormone receptors for estrogens (ER+ for more than 10% of cells) and/or progesterone (Pg+ for more than 10% of cells) or both. This expression may have been detected on the primary tumor or at a metastatic site. The method used will be reassessed by IHC if it involves a radioligand technique whenever it is possible to obtain histological material.
- Progressing on treatment with tamoxifen, given either as adjuvant treatment or for advanced/metastatic breast cancer. Any previous treatment with a steroidal or nonsteroidal antiaromatase in a neo-adjuvant, adjuvant or metastatic situation is permitted. Likewise, any previous treatment with chemotherapy and/or herceptin in a nonmetastatic situation is permitted.
- Post-menopausal patients
- Age > 18 years
- At least one measurable lesion according to the Response Evaluation Criteria for Solid Tumors (RECIST) criteria; for patients who only have bone metastases, an evaluable non-irradiated lytic lesion is required
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- Performance Status (WHO): PS ≤ 2 (Appendix 1).
- Laboratory tests in accordance with the following criteria:
- Neutrophils ≥ 2x109/l,Platelets ≥ 100x109/l,Hemoglobin ≥ 10 g/dl, ASAT, ALAT ≤ 2.5 N , or < 5 N when liver metastasis,bilirubin ≤ 1.5 N creatinin ≤ 1.5 N
- Signed, written consent before any study-related procedure
Who cannot join
- Men
- Pre-menopausal patients who are not receiving concurrent LHRH agonist therapy
- ER- and PR-negative patients
- Contraindication to antiestrogens (thromboembolic risk) or ZARNESTRA
- Non metastatic tumor susceptible to management by radiotherapeutic and/or surgical means
- T4d inflammatory tumor (PEV 2 or 3).
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- Short-term, life-threatening lesions: hepatic invasion > 1/3 of liver volume, pulmonary lymphangitis, uncontrolled cerebral metastases, carcinomatous meningitis
- Sensory neuropathy > or = grade 1 (WHO)
- Previous history of uncontrolled cancers or controlled for less than 5 years, except basal cell skin cancers and in situ cancers of the cervix.
- Chronic diseases (somatic or psychiatric) with a poor prognosis
- subjects with enzyme-inducing anti-convulsants (e.g., phenytoin, phenobarbital, carbamazepine) : this treatment is not permitted while taking ZARNESTRA
- Patients who, for family, social, geographic or psychological reasons, could not be followed up correctly.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Institut Bergonie
Bordeaux
Institut Val d'Aurelle_ Paul Lamarque
Montpellier
Institut Claudius Regaud
Toulouse
About this study
Official title: Open, Single-Arm Phase II Study Assessing Efficacy of ZARNESTRA™ Combined With Tamoxifen in Patients With Advanced or Metastatic Breast Cancer Expressing the Estrogen and/or Progesterone Receptor
The purpose of this study is to evaluate the objective response rate when ZARNESTRA is added to treatment with tamoxifen
- Conditions
- Breast Neoplasms
- Being tested
- Tamoxifen, Zarnestra
- Keywords
- Breast Neoplasms, Zarnestra, Tamoxifen, estrogen receptor, progesterone receptor
- 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
ZarnestraDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the objective response rate when ZARNESTRA is added to administration of tamoxifen in patients suffering from metastatic or advanced inoperable breast cancer, who are progressing on tamoxifen treatment
Secondary outcomes (5)
To evaluate the time to progression
To evaluate the clinical benefit (response + stable disease at 6 months)
To evaluate the safety of the combination ZARNESTRA and tamoxifen
To evaluate a possible pharmacokinetic interaction between ZARNESTRA and tamoxifen
To evaluate the biological predictive and prognostic factors of a response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startAug 2003
- Study completionAug 2008
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.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen-Cilag Ltd.
- Investigators
- Henri Roché, Pr, Principal investigator, Institut Claudius Regaud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00210028
- Sponsor's protocol ID
- 03 SEIN 04
- Status last verified
- Nov 2006
- First submitted
- 13 Sep 2005
- Last updated
- 14 Nov 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Single-Arm Phase II Study Assessing Efficacy of ZARNESTRA™ Combined With Tamoxifen in Patients With Advanced or Metastatic Breast Cancer Expressing the Estrogen and/or Progesterone Receptor
- ClinicalTrials.gov ID
- NCT00210028
- Acronym / sponsor ID
- 03 SEIN 04
- Conditions
- Breast Neoplasms
- Keywords
- Breast Neoplasms, Zarnestra, Tamoxifen, estrogen receptor, progesterone receptor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 40 participants
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Collaborators
- Janssen-Cilag Ltd.
- Study start
- Aug 2003
- Study completion
- Aug 2008
- First posted
- 21 Sep 2005 (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.
The purpose of this study is to evaluate the objective response rate when ZARNESTRA is added to treatment with tamoxifen
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
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)
- Histologically proven, metastatic or locally advanced inoperable breast cancer
- Tumor considered potentially hormone-sensitive, i.e. presence by IHC of hormone receptors for estrogens (ER+ for more than 10% of cells) and/or progesterone (Pg+ for more than 10% of cells) or both. This expression may have been detected on the primary tumor or at a metastatic site. The method used will be reassessed by IHC if it involves a radioligand technique whenever it is possible to obtain histological material.
- Progressing on treatment with tamoxifen, given either as adjuvant treatment or for advanced/metastatic breast cancer. Any previous treatment with a steroidal or nonsteroidal antiaromatase in a neo-adjuvant, adjuvant or metastatic situation is permitted. Likewise, any previous treatment with chemotherapy and/or herceptin in a nonmetastatic situation is permitted.
- Post-menopausal patients
- Age > 18 years
Key exclusion criteria (12 listed)
- Men
- Pre-menopausal patients who are not receiving concurrent LHRH agonist therapy
- ER- and PR-negative patients
- Contraindication to antiestrogens (thromboembolic risk) or ZARNESTRA
- Non metastatic tumor susceptible to management by radiotherapeutic and/or surgical means
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 |
|---|---|---|
| Tamoxifen | Drug | – |
| Zarnestra | Drug | – |
Primary outcome
To evaluate the objective response rate when ZARNESTRA is added to administration of tamoxifen in patients suffering from metastatic or advanced inoperable breast cancer, who are progressing on tamoxifen treatment
5 secondary outcomes
To evaluate the time to progression
To evaluate the clinical benefit (response + stable disease at 6 months)
To evaluate the safety of the combination ZARNESTRA and tamoxifen
To evaluate a possible pharmacokinetic interaction between ZARNESTRA and tamoxifen
To evaluate the biological predictive and prognostic factors of a response
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2006.
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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.
Henri Roché, Pr principal investigator
Institut Claudius Regaud
3 sites 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 Zarnestra in people with Breast Neoplasms, run by Institut Claudius Regaud 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 10 inclusion and 12 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: stopped early, as of the sponsor's last update on 14 Nov 2006. 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.
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 was stopped early. Results are not available in the source record.
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?
To evaluate the objective response rate when ZARNESTRA is added to administration of tamoxifen in patients suffering from metastatic or advanced inoperable breast cancer, who are progressing on tamoxifen treatment. 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 14 Nov 2006.