Breast CancerPhase 2FRIENDNCT02646735
Fulvestrant 500mg With Exemestane Endocrine Therapy for Postmenopausal Advanced Breast Cancer Patients
A Phase 2 study testing Fulvestrant 500 mg and Exemestane 25 mg in people with Breast Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
A Randomized, Open label, Parallel-group, Multi-center study. Eligible patients will be randomized in a 1:1 ratio to receive fulvestrant 500 mg or Exemestane 25mg. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Fulvestrant 500 mg and Exemestane 25 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteChina
- Study dates
- Dec 2015to Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Signed informed consent document on file;
- Age over 60 years;
- Age < 60 years and amenorrheic for 12 or more months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and FSH and oestradiol level in the postmenopausal range;
- Patients with metastatic or locally advanced disease not amenable to therapy with Curative intent
- ER + and/or PgR +;
- Duration of adjuvant non-aromatase inhibitors treatment should be at least 2 years or more;
- WHO performance status 0, 1 or 2;
- Patients with life expectancy of more than 3 months.
Who cannot join
- Presence of life-threatening metastatic visceral disease;
- Previous systemic chemotherapy for advanced breast cancer;
- Received systemic endocrine therapy for advanced disease;
- Extensive radiation therapy within the last 4 weeks ;
- Platelets < 100*109 / L,Total bilirubin no less than 1.5ULRR, ALT or AST no less than 2.5ULRR if no demonstrable liver metastases or no less than 5ULRR in presence of liver metastases;
- Severe renal impairment, bleeding diathesis, long-term anticoagulant therapy;
- History of hypersensitivity to active or inactive excipients of fulvestrant, Exemestane and/or castor oil.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
National Cancer Institute, Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Binghe XU, M.D., 86-10-88788826, xubinghe@medmail.com.cn
Jiayu WANG, M.D.
About this study
Official title: A Randomized, Open Label, Multi-Centre Study to Compare the Efficacy and Tolerability of Fulvestrant 500mg With Exemestane for Postmenopausal Advanced Breast Cancer Patients
A Randomized, Open label, Parallel-group, Multi-center study. Eligible patients will be randomized in a 1:1 ratio to receive fulvestrant 500 mg or Exemestane 25mg.
Read the detailed description
To compare the efficacy and tolerability of Fulvestrant 500 mg with Exemestane 25 mg as first line endocrine therapy in postmenopausal women with oestrogen receptor positive HER2 negative advanced breast cancer who have relapsed on or after adjuvant non-aromatase inhibitor therapy
- Conditions
- Breast Cancer
- Being tested
- Fulvestrant 500 mg, Exemestane 25 mg
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fulvestrant 500 mgDrug
Fulvestrant 500mg will be given monthly.
Exemestane 25 mgDrug
Exemestane 25mg will be given once daily.
| Study group | Role | What they receive |
|---|---|---|
| Fulvestrant | Experimental | Fulvestrant 500 mg Receives: Drug: Fulvestrant 500 mg |
| Exemestane | Active comparator | Exemestane 25mg Receives: Drug: Exemestane 25 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
To compare the efficacy of Fulvestrant 500 mg with the patients treated with Exemestane 25mg as first line setting in terms of progression-free survival.
Measured: 3 years
Secondary outcomes (1)
ORR
To compare the objective response rate of patients treated with Fulvestrant 500 mg with Exemestane.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- None (open label)
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Binghe Xu, Chinese Academy of Medical Sciences
- Investigators
- XU Binghe, MD, Principal investigator, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02646735
- Sponsor's protocol ID
- 10982
- Acronym
- FRIEND
- Status last verified
- Dec 2016
- First submitted
- 4 Jan 2016
- Last updated
- 2 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Wang J, Cai L, Song Y, Sun T, Tong Z, Teng Y, Li H, Ouyang Q, Chen Q, Cui S, Yin Y, Liao N, Sun Q, Feng J, Wang X, Xu B. Clinical efficacy of fulvestrant versus exemestane as first-line therapies for Chinese postmenopausal oestrogen-receptor positive /human epidermal growth factor receptor 2 -advanced breast cancer (FRIEND study). Eur J Cancer. 2023 May;184:73-82. doi: 10.1016/j.ejca.2023.02.007. Epub 2023 Feb 15.
PubMed 36905771
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Multi-Centre Study to Compare the Efficacy and Tolerability of Fulvestrant 500mg With Exemestane for Postmenopausal Advanced Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT02646735
- Acronym / sponsor ID
- FRIEND / 10982
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Study start
- Dec 2015
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 6 Jan 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.
A Randomized, Open label, Parallel-group, Multi-center study. Eligible patients will be randomized in a 1:1 ratio to receive fulvestrant 500 mg or Exemestane 25mg.
Detailed description
To compare the efficacy and tolerability of Fulvestrant 500 mg with Exemestane 25 mg as first line endocrine therapy in postmenopausal women with oestrogen receptor positive HER2 negative advanced breast cancer who have relapsed on or after adjuvant non-aromatase inhibitor therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fulvestrant | Experimental | Drug: Fulvestrant 500 mgFulvestrant 500 mg |
| Exemestane | Active comparator | Drug: Exemestane 25 mgExemestane 25mg |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Signed informed consent document on file;
- Age over 60 years;
- Age < 60 years and amenorrheic for 12 or more months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and FSH and oestradiol level in the postmenopausal range;
- Patients with metastatic or locally advanced disease not amenable to therapy with Curative intent
- ER + and/or PgR +;
Key exclusion criteria (7 listed)
- Presence of life-threatening metastatic visceral disease;
- Previous systemic chemotherapy for advanced breast cancer;
- Received systemic endocrine therapy for advanced disease;
- Extensive radiation therapy within the last 4 weeks ;
- Platelets < 100*109 / L,Total bilirubin no less than 1.5ULRR, ALT or AST no less than 2.5ULRR if no demonstrable liver metastases or no less than 5ULRR in presence of liver metastases;
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 |
|---|---|---|
| Fulvestrant 500 mgFulvestrant 500mg will be given monthly. | Drug | Fulvestrant |
| Exemestane 25 mgExemestane 25mg will be given once daily. | Drug | Exemestane |
Primary outcome
PFS
Time frame: 3 years
To compare the efficacy of Fulvestrant 500 mg with the patients treated with Exemestane 25mg as first line setting in terms of progression-free survival.
1 secondary outcome
ORR
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2017.
- Derived from this study: PubMed 36905771Wang J, Cai L, Song Y, Sun T, Tong Z, Teng Y, Li H, Ouyang Q, Chen Q, Cui S, Yin Y, Liao N, Sun Q, Feng J, Wang X, Xu B. Clinical efficacy of fulvestrant versus exemestane as first-line therapies for Chinese postmenopausal oestrogen-receptor positive /human epidermal growth factor receptor 2 -advanced breast cancer (FRIEND study). Eur J Cancer. 2023 May;184:73-82. doi: 10.1016/j.ejca.2023.02.007. Epub 2023 Feb 15.
- Individual participant dataSharing planned: No
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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.
XU Binghe, MD principal investigator
Chinese Academy of Medical Sciences
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 Fulvestrant 500 mg and Exemestane 25 mg in people with Breast Cancer, run by Chinese Academy of Medical Sciences 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 8 inclusion and 7 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 2 Jan 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact XU Binghe, MD (86-10-87788495 ext. 0000, wangjiayu8778@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02646735, which also lists 1 linked publication.
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 Jan 2017; AzTrials last refreshed its copy on 6 Nov 2026.