Metastatic Breast CancerPhase 2NCT02137083
A Trial Comparing Docetaxel Plus Fulvestrant With Docetaxel in Metastatic Breast Cancer
A Phase 2 study testing Docetaxel and Fulvestrant in people with Metastatic Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
Comparing Docetaxel Plus Fulvestrant With Docetaxel in Patients With Metastatic Breast Cancer Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Docetaxel and Fulvestrant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- Apr 2014to Jul 2017
- 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
- Postmenopausal female between 18 and 70 years old
- ECOG performance status of ≤ 1
- Life expectancy more than 3 months
- Histologically confirmed metastatic breast cancer
- ER and\&or PR pqositive, HER2-negative
- Disease progression during adjuvant or first-line endocrine therapy, or endocrine naive but unsuitable for endocrine therapy alone
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- No pretreated chemotherapy for metastatic disease
- Have at least one target lesion according to RECIST 1.1
- No therapy (chemotherapy, endocrine therapy, target therapy and operation) within 4 weeks before enrollment
- Hemoglobin ≥ 90 g/L, Absolute Neutrophil Count ≥ 1.5×10^9/L, Platelet Count ≥ 75×10^9/L, Serum Bilirubin ≤ 1.5×ULN, ALT and AST ≤ 1.5×ULN, Serum Creatinine ≤ 1×ULN, Endogenous Creatinine Clearance>50ml/min
Who cannot join
- Pregnant or lactating women
- Evidence of CNS metastasis
- Seriously uncontrolled infection
- History of another malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- Pretreated with Fulvestrant
- Pretreated with two or more lines of endocrine therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Single-center Randomized Phase 2 Trial Comparing Docetaxel Plus Fulvestrant With Docetaxel in Postmenopausal, Hormone-receptor Positive and HER2-negative Metastatic Breast Cancer
Comparing Docetaxel Plus Fulvestrant With Docetaxel in Patients With Metastatic Breast Cancer
Read the detailed description
Comparing Docetaxel Plus Fulvestrant With Docetaxel in Postmenopausal, Hormone-receptor Positive and HER2-negative Metastatic Breast Cancer
- Conditions
- Metastatic Breast Cancer
- Being tested
- Docetaxel, Fulvestrant
- Keywords
- Chemotherapy, Endocrine therapy, Docetaxel, Fulvestrant
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Also called Taxotere
75mg/m2 D2 every 21 days
FulvestrantDrug
Also called Faslodex
500mg D1, D15, D29, D57, every 28 days later
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel Plus Fulvestrant | Experimental | Docetaxel:75mg/m2 D2 every 21 days
Fulvestrant:500mg D1, D15, D29, D57, every 28 days later Receives: Drug: Docetaxel; Drug: Fulvestrant |
| Docetaxel | Active comparator | Docetaxel:75mg/m2 D2 every 21 days Receives: Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Measured: 6 weeks
Secondary outcomes (2)
Overall Response Rate
Measured: 6 Weeks
Overall Survival
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study startApr 2014
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xichun Hu, Fudan University
- Investigators
- Xichun Hu, MD, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02137083
- Sponsor's protocol ID
- Fudan BR2014-13
- Status last verified
- Jan 2018
- First submitted
- 6 May 2014
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single-center Randomized Phase 2 Trial Comparing Docetaxel Plus Fulvestrant With Docetaxel in Postmenopausal, Hormone-receptor Positive and HER2-negative Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT02137083
- Acronym / sponsor ID
- Fudan BR2014-13
- Conditions
- Metastatic Breast Cancer
- Keywords
- Chemotherapy, Endocrine therapy, Docetaxel, Fulvestrant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 13 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.
Comparing Docetaxel Plus Fulvestrant With Docetaxel in Patients With Metastatic Breast Cancer
Detailed description
Comparing Docetaxel Plus Fulvestrant With Docetaxel in Postmenopausal, Hormone-receptor Positive and HER2-negative Metastatic Breast Cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Docetaxel Plus Fulvestrant | Experimental | Drug: Docetaxel, Drug: FulvestrantDocetaxel:75mg/m2 D2 every 21 days Fulvestrant:500mg D1, D15, D29, D57, every 28 days later |
| Docetaxel | Active comparator | Drug: DocetaxelDocetaxel:75mg/m2 D2 every 21 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Postmenopausal female between 18 and 70 years old
- ECOG performance status of ≤ 1
- Life expectancy more than 3 months
- Histologically confirmed metastatic breast cancer
- ER and\&or PR pqositive, HER2-negative
Key exclusion criteria (6 listed)
- Pregnant or lactating women
- Evidence of CNS metastasis
- Seriously uncontrolled infection
- History of another malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- Pretreated with Fulvestrant
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 |
|---|---|---|
| DocetaxelAlso: Taxotere75mg/m2 D2 every 21 days | Drug | Docetaxel, Docetaxel Plus Fulvestrant |
| FulvestrantAlso: Faslodex500mg D1, D15, D29, D57, every 28 days later | Drug | Docetaxel Plus Fulvestrant |
Primary outcome
Progression Free Survival
Time frame: 6 weeks
2 secondary outcomes
Overall Response Rate
Time frame: 6 Weeks
Overall Survival
Time frame: 6 Weeks
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 23 Jan 2018.
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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.
Xichun Hu, MD, PhD principal investigator
Fudan University
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 Docetaxel and Fulvestrant in people with Metastatic Breast Cancer, run by Fudan University 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 10 inclusion and 6 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 23 Jan 2018. 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?
Progression Free Survival (time frame: 6 weeks). 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 23 Jan 2018.