Breast CancerPhase 3NCT02132390
Adjuvant Toremifene With or Without Goserrelin in Premenopausal Women With Stage I-IIIA, Hormonal Receptor Positive Breast Cancer Accompanied With or Without Chemotherapy Induced Amenorrhoea
A Phase 3 study testing Goserelin and Toremifene in people with Breast Cancer and Chemotherapy Induced Amenorrhea, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Compare the potential benefits of adjuvant toremifene with or without goserelin in premenopausal women with stage I-IIIA, hormonal receptor positive breast cancer accompanied with or without chemotherapy induced amenorrhoea. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Breast Cancer, Chemotherapy Induced Amenorrhea, Ovarian Function Suppression
- What is being tested?
- Goserelin and Toremifene
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- May 2014to May 2024
- Phase
- Phase 3
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures
- Age of at least 18 and at most 45 years
- Spontaneous and regular menstrual periods before study entry with FSH below 15 mlU/ml in follicular phase
- Histologically confirmed primary breast cancer with the need for anthracycline-based chemotherapy
- Steroid receptor (estrogen and progesterone) positive tumor (diagnosis according to hospital standard-procedures)
- No clinical evidence of local recurrence or distant metastases. Complete staging work-up within 3 months prior to registration. All patients must have (bilateral) mammography or breast MRI, chest X-ray; other tests may be performed as clinically indicated
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- Karnofsky-Index >80%
- Life expectancy of at least 10 years, disregarding the diagnosis of cancer
- Adequate organ function including normal red and white blood count, platelets, serum creatinine, bilirubin, and transaminases within normal range of the institution
- Patients underwent standard Doxorubicin/Cyclophosphamide Followed by Docetaxel (AC-T)
- Patients must be available for and compliant to treatment and follow-up. Patients registered on this trial must be treated and followed up at the participating center.
Who cannot join
- Known hypersensitivity reaction to the investigational compounds or incorporated substances
- Prior cytotoxic treatment for any reason
- Suspected (primary or secondary) ovarian insufficiency
- Pregnant or lactating patients. Patients of childbearing potential must have a negative pregnancy test (urine or serum) within 14 days prior to registration and must implement adequate non-hormonal contraceptive measures during study treatment; prior use of hormonal contraceptives has to be discontinued before first Goserelin injection
- Other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study
- Prior or concomitant secondary malignancy (except non-melanomatous skin cancer or carcinoma in situ of the uterine cervix)
- Concurrent treatment with other experimental drugs or any other anti-cancer therapy
- Concurrent treatment with sex hormones. Prior treatment must be stopped before study entry
Trial locations and contacts
1 site in 1 country.
Changjun WANG, Doctor contact
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Yidong ZHOU, Master, 8610-69152700, wcj_sumy@126.com
About this study
Official title: Study of Adjuvant Toremifene With or Without Goserrelin in Premenopausal Women With Stage I-IIIA, Hormonal Receptor Positive Breast Cancer Accompanied With or Without Chemotherapy Induced Amenorrhoea
Compare the potential benefits of adjuvant toremifene with or without goserelin in premenopausal women with stage I-IIIA, hormonal receptor positive breast cancer accompanied with or without chemotherapy induced amenorrhoea.
Read the detailed description
This is a single center, randomized, controlled study. Patients undergo surgical resection with standard Doxorubicin/Cyclophosphamide Followed by Docetaxel (AC-T).
Chemotherapy begins within 4 weeks after surgery for patients randomized to arm I-IV. Arm I: patients who didn't have CIA receive oral toremifene daily. Treatment continues for 5 years in the absence of disease progression or unacceptable toxicity. Arm II: patients who had CIA receive toremifene as in arm I. Arm III: patients without CIA receive oral toremifene and goserelin for ovarian function suppression. Arm IV: patients with CIA receive oral toremifene and goserelin for ovarian function suppression. Patients are followed every 6 months for 5 years and annually thereafter.
- Being tested
- Goserelin, Toremifene
- Keywords
- Breast cancer, Chemotherapy induced amenorrhea, Goserelin
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GoserelinDrug
Also called Zoladex
ToremifeneDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients who didn't have CIA receive oral toremifene daily. Treatment continues for 5 years in the absence of disease progression or unacceptable toxicity Receives: Drug: Toremifene |
| Arm II | Experimental | Patients who had CIA receive toremifene as in arm I Receives: Drug: Toremifene |
| Arm III | Experimental | Patients without CIA receive oral toremifene and goserelin for ovarian function suppression Receives: Drug: Goserelin |
| Arm IV | Experimental | Patients with CIA receive oral toremifene and goserelin for ovarian function suppression. Receives: Drug: Goserelin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
Measured: up to 120 months
Overall Survival
Measured: up to 120 months
Secondary outcomes (4)
Quality of life
Measured: up to 120 months
Bone mineral density loss
measured by dual energy X-ray absorptiometry scans at every 12 months and by serum biomarkers
Measured: up to 120 months
Hormone levels
Measured: up to 120 months
Incidence of pregnancy
Measured: up to 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2024 (estimated)
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 Peking Union Medical College HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZHOU Yidong, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02132390
- Sponsor's protocol ID
- PUMCH-Breast-CIA
- Status last verified
- Jun 2014
- First submitted
- 5 May 2014
- Last updated
- 4 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Adjuvant Toremifene With or Without Goserrelin in Premenopausal Women With Stage I-IIIA, Hormonal Receptor Positive Breast Cancer Accompanied With or Without Chemotherapy Induced Amenorrhoea
- ClinicalTrials.gov ID
- NCT02132390
- Acronym / sponsor ID
- PUMCH-Breast-CIA
- Keywords
- Breast cancer, Chemotherapy induced amenorrhea, Goserelin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2024 (estimated)
- First posted
- 7 May 2014 (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.
Compare the potential benefits of adjuvant toremifene with or without goserelin in premenopausal women with stage I-IIIA, hormonal receptor positive breast cancer accompanied with or without chemotherapy induced amenorrhoea.
Detailed description
This is a single center, randomized, controlled study. Patients undergo surgical resection with standard Doxorubicin/Cyclophosphamide Followed by Docetaxel (AC-T).
Chemotherapy begins within 4 weeks after surgery for patients randomized to arm I-IV. Arm I: patients who didn't have CIA receive oral toremifene daily. Treatment continues for 5 years in the absence of disease progression or unacceptable toxicity. Arm II: patients who had CIA receive toremifene as in arm I. Arm III: patients without CIA receive oral toremifene and goserelin for ovarian function suppression. Arm IV: patients with CIA receive oral toremifene and goserelin for ovarian function suppression. Patients are followed every 6 months for 5 years and annually thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: ToremifenePatients who didn't have CIA receive oral toremifene daily. Treatment continues for 5 years in the absence of disease progression or unacceptable toxicity |
| Arm II | Experimental | Drug: ToremifenePatients who had CIA receive toremifene as in arm I |
| Arm III | Experimental | Drug: GoserelinPatients without CIA receive oral toremifene and goserelin for ovarian function suppression |
| Arm IV | Experimental | Drug: GoserelinPatients with CIA receive oral toremifene and goserelin for ovarian function suppression. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures
- Age of at least 18 and at most 45 years
- Spontaneous and regular menstrual periods before study entry with FSH below 15 mlU/ml in follicular phase
- Histologically confirmed primary breast cancer with the need for anthracycline-based chemotherapy
- Steroid receptor (estrogen and progesterone) positive tumor (diagnosis according to hospital standard-procedures)
Key exclusion criteria (8 listed)
- Known hypersensitivity reaction to the investigational compounds or incorporated substances
- Prior cytotoxic treatment for any reason
- Suspected (primary or secondary) ovarian insufficiency
- Pregnant or lactating patients. Patients of childbearing potential must have a negative pregnancy test (urine or serum) within 14 days prior to registration and must implement adequate non-hormonal contraceptive measures during study treatment; prior use of hormonal contraceptives has to be discontinued before first Goserelin injection
- Other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study
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 |
|---|---|---|
| GoserelinAlso: Zoladex | Drug | Arm III, Arm IV |
| Toremifene | Drug | Arm I, Arm II |
Primary outcome
Disease free survival
Time frame: up to 120 months
Overall Survival
Time frame: up to 120 months
4 secondary outcomes
Quality of life
Time frame: up to 120 months
Bone mineral density loss
Time frame: up to 120 months
Hormone levels
Time frame: up to 120 months
Incidence of pregnancy
Time frame: up to 120 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2014.
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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.
Changjun WANG, Doctor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Goserelin and Toremifene in people with Breast Cancer and Chemotherapy Induced Amenorrhea, run by Peking Union Medical College Hospital at 1 site in China.
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 11 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 4 Jun 2014. 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 China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yidong ZHOU, Master (0086-10-69152700, wcj_sumy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (time frame: up to 120 months). The study lists 2 primary outcomes in all. 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 4 Jun 2014.