Breast CancerPhase 2NCT00464516
Preoperative Estetrol in Breast Cancer
A Phase 2 study testing Estetrol in people with Breast Cancer, run by Pantarhei Bioscience at 1 site in Austria.
Trial summary
The study is designed as a single-center, randomized, double-blind, placebo-controlled study in pre- and postmenopausal women who will undergo surgery for breast cancer. Subjects will either receive estetrol or placebo during a 2 week treatment period. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Estetrol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- Apr 2007to Mar 2010
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of early invasive primary breast cancer (clinically stage I or II; T1 - T2; N0-1; M0, which requires surgery).
- The malignant tumor must be estrogen receptor (ER) positive as determined by the local pathologist. Weak, intermediate and strong staining is considered appropriate for inclusion.
- The breast tumor size must be adequate for core cut biopsy to obtain sufficient amount of tissue for gene and protein expression analysis.
- Subjects will be either pre- or post-menopausal.
- The postmenopausal study group has been defined as follows: not older than 70 years of age and a natural menopause with the last menstrual bleeding at least 12 months before the start of the study. If the date of last menstruation is uncertain because of perimenopausal HRT or in case of past hysterectomy with intact ovaries, then the subject must have appropriate FSH and Estradiol (E2) levels (FSH > 40 International Units (IU)/L and E2 < 20 pg/ml (=73.40 pmol/l)) after completion of a HRT wash-out according to exclusion criterion 2 and 3.
- The premenopausal study group has been defined as follows: At least 18 years and not older than 50 years of age with at least one spontaneous menstrual bleeding during the last 6 months, combined with an FSH level below 10 IU/L. Before treatment starts a pregnancy test will be performed that has to be negative. If appropriate a barrier method of contraception has to be used for the duration of the study. The criteria for perimenopausal HRT wash-out are according to exclusion criterion 2 and 3.
- BMI must be between 18 and 32 kg/m2.
- The patient must provide voluntary written informed consent.
Who cannot join
- Any serious disease (e.g. severe liver or renal disease), clinically significant abnormal laboratory values (e.g. abnormal serum liver enzyme concentrations above the upper safety limit) or any other clinically significant abnormalities which, in the investigator's opinion, may lead to adverse events during the course of the trial
- Previous use of estrogen/progestogen within:
- 6 months for depot preparations.
- 8 weeks for oral preparations or progestogen containing IUD.
- 4 weeks for transdermal preparations
- Use of hormone containing implant at any time
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- Contraindications for using steroids:
- A history of, or existing thromboembolic, cardiovascular or cerebrovascular disorder.
- A history of, or existing conditions predisposing to, or being prodromi of, a thrombosis.
- A known defect in the blood coagulation system (e.g. deficiencies in AT-III, protein C, S, and APC resistance).
- A medical history positive for the presence of more than one risk factor for vascular disease (e.g. dyslipoproteinemia; diabetes mellitus; hyperhomocysteinemia; systemic lupus erythematosus; chronic inflammatory bowel disease; smoking; venous thromboembolism in sibling or parent below the age of 50, or arterial disease in sibling or parent below the age of 30-35).
- Hypertension, i.e. systolic blood pressure >160 mm Hg and/or diastolic blood pressure >100 mm Hg.
- Disturbance of liver function: cholestatic jaundice, a history of jaundice of pregnancy or jaundice due to previous estrogen use, Rotor syndrome and Dubin-Johnson syndrome.
- Any previous hormone-related malignancies within the last 5 years. History or presence of endometrial cancer. Exceptions are basaliomas of the skin and intraepithelial cervical neoplasias (CIN1-3).
- Undiagnosed vaginal bleeding.
- Porphyria.
- A history during pregnancy or previous estrogen use of severe pruritus, herpes gestationis or deterioration of otosclerosis.
- Presence of significant allergy
- Administration of investigational drugs within 3 months before start study medication
- A history of (within 12 months) alcohol or drug abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Hormone Therapy for Pre- and Postmenopausal Women With ER Positive Breast Cancer: A Double Blind Randomized Parallel Group Phase II Trial, Comparing the Effect of 2 Weeks of Preoperative Estetrol With Placebo
The study is designed as a single-center, randomized, double-blind, placebo-controlled study in pre- and postmenopausal women who will undergo surgery for breast cancer. Subjects will either receive estetrol or placebo during a 2 week treatment period.
Several biological markers, such as a cellular growth marker and cell death markers, will be assessed in the tumor tissue and surrounding normal tissue before and after the treatment period. During the 2 week interval between diagnosis of breast cancer and surgical resection, no therapy for breast cancer is usually administered.
Read the detailed description
The study is designed as a single-center, randomized, double-blind, placebo-controlled study in pre- and postmenopausal women who will undergo surgery for breast cancer. Subjects will either receive estetrol or placebo during a 2 week treatment period.
Several biological markers, such as a cellular growth marker and cell death markers, will be assessed in the tumor tissue and surrounding normal tissue before and after the treatment period. In addition, receptor studies will be performed. During the 2 week interval between diagnosis of breast cancer and surgical resection, no therapy for breast cancer is usually administered.
- Conditions
- Breast Cancer
- Being tested
- placebo, Estetrol
- Keywords
- Breast cancer (Estrogen Receptor positive)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
once daily for 14 days orally
EstetrolDrug
once daily for 14 days orally
| Study group | Role | What they receive |
|---|---|---|
| estetrol | Experimental | Not described Receives: Drug: Estetrol |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare changes in the expression of a proliferation marker in malignant breast tissue after treatment with E4 or Placebo.
Measured: 14 days
Secondary outcomes (4)
To investigate treatment effects of Estetrol on apoptosis and apoptosis-related proteins in tumor tissue and in adjacent normal breast tissue.
Measured: 14 days
To investigate hormone receptors, serum hormone levels and estetrol levels.
Measured: 14 days
To investigate the effect of estetrol on the endometrium in women with an intact uterus.
Measured: 14 days
To determine safety and tolerability of estetrol in women with Estrogen Receptor (ER) positive breast cancer
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionFeb 2009
- Study completionMar 2010
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.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pantarhei Bioscience
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christian F Singer, MD, MPH, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00464516
- Sponsor's protocol ID
- PR3076
- Status last verified
- Jun 2012
- First submitted
- 20 Apr 2007
- Last updated
- 2 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Hormone Therapy for Pre- and Postmenopausal Women With ER Positive Breast Cancer: A Double Blind Randomized Parallel Group Phase II Trial, Comparing the Effect of 2 Weeks of Preoperative Estetrol With Placebo
- ClinicalTrials.gov ID
- NCT00464516
- Acronym / sponsor ID
- PR3076
- Conditions
- Breast Cancer
- Keywords
- Breast cancer (Estrogen Receptor positive)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Pantarhei BioscienceIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 23 Apr 2007 (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 study is designed as a single-center, randomized, double-blind, placebo-controlled study in pre- and postmenopausal women who will undergo surgery for breast cancer. Subjects will either receive estetrol or placebo during a 2 week treatment period.
Several biological markers, such as a cellular growth marker and cell death markers, will be assessed in the tumor tissue and surrounding normal tissue before and after the treatment period. During the 2 week interval between diagnosis of breast cancer and surgical resection, no therapy for breast cancer is usually administered.
Detailed description
The study is designed as a single-center, randomized, double-blind, placebo-controlled study in pre- and postmenopausal women who will undergo surgery for breast cancer. Subjects will either receive estetrol or placebo during a 2 week treatment period.
Several biological markers, such as a cellular growth marker and cell death markers, will be assessed in the tumor tissue and surrounding normal tissue before and after the treatment period. In addition, receptor studies will be performed. During the 2 week interval between diagnosis of breast cancer and surgical resection, no therapy for breast cancer is usually administered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| estetrol | Experimental | Drug: Estetrol |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed diagnosis of early invasive primary breast cancer (clinically stage I or II; T1 - T2; N0-1; M0, which requires surgery).
- The malignant tumor must be estrogen receptor (ER) positive as determined by the local pathologist. Weak, intermediate and strong staining is considered appropriate for inclusion.
- The breast tumor size must be adequate for core cut biopsy to obtain sufficient amount of tissue for gene and protein expression analysis.
- Subjects will be either pre- or post-menopausal.
- BMI must be between 18 and 32 kg/m2.
Key exclusion criteria (20 listed)
- Any serious disease (e.g. severe liver or renal disease), clinically significant abnormal laboratory values (e.g. abnormal serum liver enzyme concentrations above the upper safety limit) or any other clinically significant abnormalities which, in the investigator's opinion, may lead to adverse events during the course of the trial
- Previous use of estrogen/progestogen within:
- Use of hormone containing implant at any time
- Contraindications for using steroids:
- Presence of significant allergy
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 |
|---|---|---|
| placeboonce daily for 14 days orally | Drug | placebo |
| Estetrolonce daily for 14 days orally | Drug | estetrol |
Primary outcome
To compare changes in the expression of a proliferation marker in malignant breast tissue after treatment with E4 or Placebo.
Time frame: 14 days
4 secondary outcomes
To investigate treatment effects of Estetrol on apoptosis and apoptosis-related proteins in tumor tissue and in adjacent normal breast tissue.
Time frame: 14 days
To investigate hormone receptors, serum hormone levels and estetrol levels.
Time frame: 14 days
To investigate the effect of estetrol on the endometrium in women with an intact uterus.
Time frame: 14 days
To determine safety and tolerability of estetrol in women with Estrogen Receptor (ER) positive breast cancer
Time frame: 21 days
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 2 Jul 2012.
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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.
Christian F Singer, MD, MPH principal investigator
Medical University of Vienna
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 Estetrol in people with Breast Cancer, run by Pantarhei Bioscience at 1 site in Austria.
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 8 inclusion and 20 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 2 Jul 2012. 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 Austria. 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. Some participants in this study may receive a placebo. 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?
To compare changes in the expression of a proliferation marker in malignant breast tissue after treatment with E4 or Placebo. (time frame: 14 days). 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 2 Jul 2012.