Breast CancerPhase 2SEATNCT02440230
Safety of OFS Combined With AI Endocrine Therapy in Chinese Premenopausal Breast Cancer Patients
A Phase 2 study testing OFS + Anastrozole and OFS + Exemestane in people with Breast Cancer, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
To compare safety of adjuvant OFS combined with anastrozole versus OFS combined with exemestane in Chinese premenopausal hormonal receptor(HR) positive breast cancer patients. 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?
- OFS + Anastrozole and OFS + Exemestane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- May 2015to Dec 2021
- 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
- Women aged ≥18 years;
- Histologically confirmed invasive breast cancer by core needle biopsy or surgery,hormonal receptor positive, defined as estrogen receptor(ER)/progesterone receptor(PR) positive;
- Premenopausal defined as
- who have been menstruating regularly during the 6 months prior to randomization and have not used any form of hormonal contraception or any other hormonal treatments during the 6 months prior to randomization.
- premenopausal status confirmed by an estradiol (E2) in the premenopausal range after chemotherapy related amenorrhea;
- Patients must have received standard local therapy: normalized modified radical mastectomy or breast conserving surgery with negative margin and post-surgical radiotherapy. Patient should completed adjuvant therapy according to conditions, including adjuvant radiotherapy, neoadjuvant or adjuvant chemotherapy;
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- Patients who did not receive chemotherapy should be randomized within 24 weeks after definitive surgery.Patients who received prior adjuvant and/or neoadjuvant chemotherapy should be randomized after completing chemotherapy and within 8 months of the final dose of chemotherapy as soon as premenopausal status is confirmed;
- Leukocyte ≥ 3*109/L; Platelets ≥ 75*109/L; Serum glutamate;
- oxaloacetate(AST/SGOT) or serum glutamic-pyruvic transaminase(ALT/SGPT) <2.5 times of upper limit of normal (UNL) range;
- Serum creatinine/blood urea nitrogen(BUN) ≤ upper limit of normal (UNL) range;
- Written informed consent according to the local ethics committee requirements.
- Has Eastern Cooperative Oncology Group(ECOG) Performance Score 0-2;
Who cannot join
- Histologically confirmed hormonal receptor negative.
- Post-menopausal.
- Patients with inoperable local advanced breast cancer including inflammatory breast cancer or supraclavicular node involvement or with enlarged internal mammary nodes (unless pathologically negative).
- Definitive surgery was done over 24 weeks before randomization for patients who did not receive chemotherapy.The final dose of chemotherapy was completed over 8 months before randomization for patients who received prior adjuvant and/or neoadjuvant chemotherapy.
- Pregnant or lactating.
- Patients with previous or concomitant invasive malignancy are not eligible. The exceptions are patients with the following (and only the following) malignancies (previous or concomitant) who are eligible if adequately treated: basal or squamous cell carcinoma of the skin in situ non-breast carcinoma without invasion contra- or ipsilateral in situ breast carcinoma non-breast invasive malignancy diagnosed at least 5 years ago and without recurrence:
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- stage I papillary thyroid cancer
- stage Ia carcinoma of the cervix
- stage Ia or b endometrioid endometrial cancer
- borderline or stage I ovarian cancer
- Patients who received endocrine therapy (including neoadjuvant and adjuvant) for more than 8 months after their breast cancer diagnosis.
- Patients who were taking tamoxifen or other selective estrogen receptor modulator (SERM,e.g. Raloxifene) or hormone replacement therapy (HRT) within one year prior to their breast cancer diagnosis.
- Patients who have had a bilateral oophorectomy or ovarian irradiation prior to their breast cancer diagnosis.
- With severe hepatic dysfunction, Child-Pugh C.
- With severe cardiac dysfunction, New York Heart Association (NYHA) grading III or worse.
- Known severe hypersensitivity to any drugs in this study.
- Participants of other experimental drug clinical trials
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
About this study
Official title: Safety of Ovarian Function Suppression(OFS)Combined With Different Aromatase Inhibitors(AIs) Endocrine Therapy in Chinese Premenopausal Breast Cancer Patients：A Randomized, Controlled, Prospective, Observational Study
To compare safety of adjuvant OFS combined with anastrozole versus OFS combined with exemestane in Chinese premenopausal hormonal receptor(HR) positive breast cancer patients.
- Conditions
- Breast Cancer
- Being tested
- OFS + Anastrozole, OFS + Exemestane
- Keywords
- adjuvant endocrine therapy, safety, Exemestane, ovarian function suppression, anastrozole
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OFS + AnastrozoleDrug
Also called OFS + Ana
Ovarian function suppression can be achieved by choice of goserelin at a dose of 3.6 mg administered by means of subcutaneous injection every 28 days,bilateral oophorectomy,or bilateral ovarian irradiation.
Patients will take anastrozole 1mg qd.
OFS + ExemestaneDrug
Also called OFS + EXE
Patients will take exemestane 25mg qd. Ovarian function suppression can be achieved by choice of goserelin at a dose of 3.6 mg administered by means of subcutaneous injection every 28 days,bilateral oophorectomy,or bilateral ovarian irradiation.
| Study group | Role | What they receive |
|---|---|---|
| OFS + Anastrozole | Experimental | Patients who were anticipated to receive adjuvant OFS+AI endocrine therapy according to MDT discussion results were randomized to this arm,they will receive OFS+Anastrozole. Receives: Drug: OFS + Anastrozole |
| OFS + Exemestane | Active comparator | Patients who were anticipated to receive adjuvant OFS+AI endocrine therapy according to MDT discussion results were randomized to this arm,they will receive OFS+Exemestane. Receives: Drug: OFS + Exemestane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of bone or joint pains
Bone and joint pains are measured by National Cancer Institute Common Toxicity Criteria for Adverse Effects (NCI CTCAE) classification v4.0 every 3 months.
Measured: participants will be followed at 0,3,6,9,12 months from enrollment.
Secondary outcomes (1)
peri-menapausal syndrome
Measured: KMI score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2021
- Study completionDec 2021
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 Shanghai Jiao Tong University School of MedicineThe 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kunwei Shen, Shanghai Jiao Tong University School of Medicine
- Investigators
- Kunwei Shen, Professor, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02440230
- Sponsor's protocol ID
- RJBC1503
- Acronym
- SEAT
- Status last verified
- Dec 2022
- First submitted
- 2 May 2015
- Last updated
- 30 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Ovarian Function Suppression(OFS)Combined With Different Aromatase Inhibitors(AIs) Endocrine Therapy in Chinese Premenopausal Breast Cancer Patients：A Randomized, Controlled, Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT02440230
- Acronym / sponsor ID
- SEAT / RJBC1503
- Conditions
- Breast Cancer
- Keywords
- adjuvant endocrine therapy, safety, Exemestane, ovarian function suppression, anastrozole
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 12 May 2015 (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.
To compare safety of adjuvant OFS combined with anastrozole versus OFS combined with exemestane in Chinese premenopausal hormonal receptor(HR) positive breast cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OFS + Anastrozole | Experimental | Drug: OFS + AnastrozolePatients who were anticipated to receive adjuvant OFS+AI endocrine therapy according to MDT discussion results were randomized to this arm,they will receive OFS+Anastrozole. |
| OFS + Exemestane | Active comparator | Drug: OFS + ExemestanePatients who were anticipated to receive adjuvant OFS+AI endocrine therapy according to MDT discussion results were randomized to this arm,they will receive OFS+Exemestane. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Women aged ≥18 years;
- Histologically confirmed invasive breast cancer by core needle biopsy or surgery,hormonal receptor positive, defined as estrogen receptor(ER)/progesterone receptor(PR) positive;
- Premenopausal defined as
- Patients must have received standard local therapy: normalized modified radical mastectomy or breast conserving surgery with negative margin and post-surgical radiotherapy. Patient should completed adjuvant therapy according to conditions, including adjuvant radiotherapy, neoadjuvant or adjuvant chemotherapy;
- Patients who did not receive chemotherapy should be randomized within 24 weeks after definitive surgery.Patients who received prior adjuvant and/or neoadjuvant chemotherapy should be randomized after completing chemotherapy and within 8 months of the final dose of chemotherapy as soon as premenopausal status is confirmed;
Key exclusion criteria (17 listed)
- Histologically confirmed hormonal receptor negative.
- Post-menopausal.
- Patients with inoperable local advanced breast cancer including inflammatory breast cancer or supraclavicular node involvement or with enlarged internal mammary nodes (unless pathologically negative).
- Definitive surgery was done over 24 weeks before randomization for patients who did not receive chemotherapy.The final dose of chemotherapy was completed over 8 months before randomization for patients who received prior adjuvant and/or neoadjuvant chemotherapy.
- Pregnant or lactating.
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 |
|---|---|---|
| OFS + AnastrozoleAlso: OFS + AnaOvarian function suppression can be achieved by choice of goserelin at a dose of 3.6 mg administered by means of subcutaneous injection every 28 days,bilateral oophorectomy,or bilateral ovarian irradiation. Patients will take anastrozole 1mg qd. | Drug | OFS + Anastrozole |
| OFS + ExemestaneAlso: OFS + EXEPatients will take exemestane 25mg qd. Ovarian function suppression can be achieved by choice of goserelin at a dose of 3.6 mg administered by means of subcutaneous injection every 28 days,bilateral oophorectomy,or bilateral ovarian irradiation. | Drug | OFS + Exemestane |
Primary outcome
Incidence of bone or joint pains
Time frame: participants will be followed at 0,3,6,9,12 months from enrollment.
Bone and joint pains are measured by National Cancer Institute Common Toxicity Criteria for Adverse Effects (NCI CTCAE) classification v4.0 every 3 months.
1 secondary outcome
peri-menapausal syndrome
Time frame: KMI score
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 30 Dec 2022.
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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.
Kunwei Shen, Professor principal investigator
Ruijin Hospital
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 OFS + Anastrozole and OFS + Exemestane in people with Breast Cancer, run by Shanghai Jiao Tong University School of Medicine 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 12 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 30 Dec 2022. 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 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?
Incidence of bone or joint pains (time frame: participants will be followed at 0,3,6,9,12 months from enrollment.). 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 30 Dec 2022.