Breast CancerPhase 2BESTNCT02853071
Efficacy and Safety of Estracyt® in Metastatic Breast Cancer
A Phase 2 study testing Estramustine and standard practice in people with Breast Cancer, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
This study evaluates efficacy, safety and quality of life in patients affected by metastatic breast cancer RH+/ HER2- and treated by estramustine phosphate. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Estramustine and standard practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2017to Jan 2020
- 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
- Metastatic breast cancer HER2-/RH+
- Progression after hormonotherapy
- Treated by taxanes, anthracyclines, capecitabine and eribulin
- Treated by everolimus
- ECOG ≤ 2
- Hematological Function: neutrophiles ≥ 1,5 x 109 / L, hemoglobin ≥ 9 g / dL, plaques ≥ 100 x 109 / L
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- Hepatic function: albumin ≥ 2,5 g / dl, bilirubin serum ≤ 2 x N (superior border of the standard) (unless disease of Gilbert), transaminases ≥ 3 x N
- Renal Function: serum creatinine ≤ 1,5 mg / dL or clearance of the creatinine ≥ 40 mL / min
- Estimated Life expectancy ≥ 3 months
Who cannot join
- Hypersensitivity known about one of the constituents of the estramustine phosphates
- Preliminary Treatment by estramustine phosphates
- Brain Metastases
- Patients not being under effective contraception
- Minor, pregnant or lactating Patients
- Patients not previously treated by everolimus
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- Transaminases > 3xN
- Other concomitant anticancer treatment less than 1 month before the inclusion
- Digestive function: malabsorption
- History of other cancer in the previous 5 years (other than squamous-cell epithelioma or totally resected in situ carcinoma)
- Active Thrombo-phlebitis
- Risk thromboembolic known,
- Unchecked cardiovascular Pathology
- Grave hepatic Affection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Estracyt® in Metastatic Breast Cancer Hormonal Estrogen Receptor (HER 2) Negative, Hormone Receptor (HR) Positive.
This study evaluates efficacy, safety and quality of life in patients affected by metastatic breast cancer RH+/ HER2- and treated by estramustine phosphate.
Read the detailed description
For patients affected by metastatic breast cancer RH+/HER2-, the conventional treatment is hormonotherapy. But, when patients don't react no recommendations exist.
Estramustine phosphate is currently prescribed for prostate cancer. The estramustine phosphate is an active anti-tumoral agent by oral route, associating a nitrogenous mustard with the estradiol, it settles on membrane receptor and the cytotoxic component acts essentially by dismantling microtubules inhibiting the mitosis.
Estramustine could be a therapeutic option when currently therapy are exhausted for patients reactive to hormonotherapy previous lines or chemotherapy.
- Conditions
- Breast Cancer
- Being tested
- Estramustine, standard practice
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EstramustineDrug
Also called estracyt, estramustine phosphate
standard practiceDrug
standard practice
| Study group | Role | What they receive |
|---|---|---|
| Estramustine | Experimental | 560 mg per day Receives: Drug: Estramustine |
| Standard practice center | Active comparator | Standard treatment center choice.
Excepted: anthracyclines, taxanes, capecitabine and eribulin Receives: Drug: standard practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of the alive patients without progress of the disease
Measured: 3 months
Secondary outcomes (3)
quality of life
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 items (EORTC QLQ-C30)
Measured: 18 months
progression-free survival
Measured: 18 months
overall survival
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study startJan 2017
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
Why it stopped: withdrawal industrial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02853071
- Sponsor's protocol ID
- P/2015/269
- Acronym
- BEST
- Status last verified
- Nov 2019
- First submitted
- 29 Jul 2016
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The Committee shall meet twice a year
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Estracyt® in Metastatic Breast Cancer Hormonal Estrogen Receptor (HER 2) Negative, Hormone Receptor (HR) Positive.
- ClinicalTrials.gov ID
- NCT02853071
- Acronym / sponsor ID
- BEST / P/2015/269
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: withdrawal industrial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 2 Aug 2016 (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 study evaluates efficacy, safety and quality of life in patients affected by metastatic breast cancer RH+/ HER2- and treated by estramustine phosphate.
Detailed description
For patients affected by metastatic breast cancer RH+/HER2-, the conventional treatment is hormonotherapy. But, when patients don't react no recommendations exist.
Estramustine phosphate is currently prescribed for prostate cancer. The estramustine phosphate is an active anti-tumoral agent by oral route, associating a nitrogenous mustard with the estradiol, it settles on membrane receptor and the cytotoxic component acts essentially by dismantling microtubules inhibiting the mitosis.
Estramustine could be a therapeutic option when currently therapy are exhausted for patients reactive to hormonotherapy previous lines or chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Estramustine | Experimental | Drug: Estramustine560 mg per day |
| Standard practice center | Active comparator | Drug: standard practiceStandard treatment center choice. Excepted: anthracyclines, taxanes, capecitabine and eribulin |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Metastatic breast cancer HER2-/RH+
- Progression after hormonotherapy
- Treated by taxanes, anthracyclines, capecitabine and eribulin
- Treated by everolimus
- ECOG ≤ 2
Key exclusion criteria (14 listed)
- Hypersensitivity known about one of the constituents of the estramustine phosphates
- Preliminary Treatment by estramustine phosphates
- Brain Metastases
- Patients not being under effective contraception
- Minor, pregnant or lactating Patients
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 |
|---|---|---|
| EstramustineAlso: estracyt, estramustine phosphate | Drug | Estramustine |
| standard practicestandard practice | Drug | Standard practice center |
Primary outcome
Proportion of the alive patients without progress of the disease
Time frame: 3 months
3 secondary outcomes
quality of life
Time frame: 18 months
progression-free survival
Time frame: 18 months
overall survival
Time frame: 18 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- Individual participant dataSharing planned: Yes. The Committee shall meet twice a year
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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 Estramustine and standard practice in people with Breast Cancer, run by Centre Hospitalier Universitaire de Besancon 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 9 inclusion and 14 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: withdrawn, as of the sponsor's last update on 18 Nov 2019. 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 was withdrawn before enrolling participants, so there are no results.
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?
Proportion of the alive patients without progress of the disease (time frame: 3 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 18 Nov 2019.