Breast Cancer FemalePhase 3NCT02980965
Neoadjuvant Chemo-endocrine Therapy Versus Chemotherapy Alone in ER-positive, HER2-negative Breast Cancer
A Phase 3 study testing letrozole, leuprorelin, fluorouracil, epirubicin, cyclophosphamide, docetaxel and fluorouracil, epirubicin, cyclophosphamide, docetaxel in people with Breast Cancer Female, run by Fudan University at 1 site in China.
Trial summary
This was an open-label, randomized controlled trial that aims to compare the efficacy and safety of the concurrent neoadjuvant chemotherapy with endocrine therapy and neoadjuvant chemotherapy alone in ER-positive, HER2-negative breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- letrozole, leuprorelin, fluorouracil, epirubicin, cyclophosphamide, docetaxel and fluorouracil, epirubicin, cyclophosphamide, docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 249 participants
- Where
- 1 siteChina
- Study dates
- May 2013to Feb 2017
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Estrogen receptor-positive and HER2-negative breast cancer patients, with histological stage of IIa-IIIc.
- Without previous chemotherapy or endocrine therapy.
- ECOG scores of 0-2 points
- With measurable and evaluable breast tumor pathologically confirmed as invasive ductal carcinoma
- Age: 18-70 years
- Lateral breast cancer
- Normal or acceptable kidney, liver, cardiovascular, and bone marrow functions
Who cannot join
- Pregnant women or nursing mothers
- With distant metastasis
- With a history of malignant tumor or complicated with other malignant tumors in addition to breast cancer, except for non-melanoma skin cancer, in situ cervical cancer or other cured malignant tumor without the basis of recurrence for at least five years
- With mental illness or other conditions affecting the patient compliance
- With other serious diseases or medical conditions:
- Congestive heart failure or unstable angina pectoris, myocardial infarction within 6 months before the enrollment, uncontrolled hypertension and uncontrolled high-risk arrhythmia considered by the investigator
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- Obvious neurological or psychiatric disorders, including psychosis, epileptic dementia and other diseases may affect the understanding and sign of the informed consent for
- Uncontrolled acute infection
- Concurrent use of other investigational drugs; or participating in other clinical trials involving investigational drugs within 30 days before this study
- With allergic constitution and any known or suspected drug allergy
- Not suitable for the trial considered by the investigator
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Hospital/ Institute, Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: A Randomized Controlled Study to Evaluate the Efficacy and Safety of Endocrine Therapy Plus Chemotherapy Versus Chemotherapy Alone as the Neoadjuvant Therapy in the Treatment of ER-positive, HER2-negative Breast Cancer (IIa-IIIc)
This was an open-label, randomized controlled trial that aims to compare the efficacy and safety of the concurrent neoadjuvant chemotherapy with endocrine therapy and neoadjuvant chemotherapy alone in ER-positive, HER2-negative breast cancer.
Read the detailed description
Data showed that concurrent neoadjuvant chemotherapy with endocrine therapy was a effective option for ER-positive, HER2-negative breast cancer patients. However this is still a controversial issue. The present study is an open-label randomized controlled clinical trial that aims to investigate the efficacy of concurrent NCT with endocrine therapy (AI with or without GnRH-a) in patients with ER-positive, HER2-negative breast carcinoma.
- Conditions
- Breast Cancer Female
- Being tested
- letrozole, leuprorelin, fluorouracil, epirubicin, cyclophosphamide, docetaxel, fluorouracil, epirubicin, cyclophosphamide, docetaxel
- Keywords
- breast cancer, neoadjuvant chemotherapy, endocrine therapy, concurrent
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
letrozole, leuprorelin, fluorouracil, epirubicin, cyclophosphamide, docetaxelDrug
Also called GnRH-a, ENANTONE
Postmenopausal patients were treated with letrozole 2.5mg/day p.o until complement of neoadjuvant chemotherapy before surgery, while premenopausal ones received letrozole 2.5mg/day p.o and a subcutaneous injection of the GnRH-a, leuprorelin, as concomitant treatment with neoadjuvant chemotherapy (fluorouracil 600mg/m2 IV, epirubicin 90mg/m2 IV and cyclophosphamide 600mg/m2 IV on day 1 at 3-weekly intervals for 3 cycles followed by docetaxel 100mg/m2 IV on day 1 at 3-weekly intervals for 3 cycles; or epirubicin 90mg/m2 IV and cyclophosphamide 600mg/m2 IV on day 1 at 2-weekly intervals for 4 cycles, followed by docetaxel 80mg/m2 IV on day 1 at 2-weekly intervals for 4 cycles), letrozole was delivered after 1 week of first dose of leuprorelin injection.
fluorouracil, epirubicin, cyclophosphamide, docetaxelDrug
Patients received fluorouracil 500mg/m2 IV, epirubicin 90mg/m2 IV and cyclophosphamide 500mg/m2 IV on day 1 at 3-weekly intervals for 3 cycles followed by docetaxel 100mg/m2 IV on day 1 at 3-weekly intervals for 3 cycles; or epirubicin 90mg/m2 IV and cyclophosphamide 600mg/m2 IV on day 1 at 2-weekly intervals for 4 cycles, followed by docetaxel 100mg/m2 IV on day 1 at 2-weekly intervals for 4 cycles.
| Study group | Role | What they receive |
|---|---|---|
| neoadjuvant chemo-endocrine therapy | Experimental | In the experimental arm, patients received concurrent chemotherapy (fluorouracil 500mg/m2 IV, epirubicin 90mg/m2 IV and cyclophosphamide 500mg/m2 IV on day 1 at 3-weekly intervals for 3 cycles followed by docetaxel 100mg/m2 IV on day 1 at 3-weekly intervals for 3 cycles; or epirubicin 90mg/m2 IV and cyclophosphamide 600mg/m2 IV on day 1 at 2-weekly intervals for 4 cycles, followed by docetaxel 100mg/m2 IV on day 1 at 2-weekly intervals for 4 cycles) with endocrine therapy (letrozole with or without leuprorelin) as a neoadjuvant treatment Receives: Drug: letrozole, leuprorelin, fluorouracil, epirubicin, cyclophosphamide, docetaxel |
| neoadjuvant chemotherapy alone | Active comparator | In the control group, patients received neoadjuvant chemotherapy alone (fluorouracil 500mg/m2 IV, epirubicin 90mg/m2 IV and cyclophosphamide 500mg/m2 IV on day 1 at 3-weekly intervals for 3 cycles followed by docetaxel 100mg/m2 IV on day 1 at 3-weekly intervals for 3 cycles; or epirubicin 90mg/m2 IV and cyclophosphamide 600mg/m2 IV on day 1 at 2-weekly intervals for 4 cycles, followed by docetaxel 100mg/m2 IV on day 1 at 2-weekly intervals for 4 cycles) Receives: Drug: fluorouracil, epirubicin, cyclophosphamide, docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate (ORR)
the proportion of patients achieving clinical complete response and partial response in the breast based on magnetic resonance imaging
Measured: 4 years
Secondary outcomes (5)
Ki67 proliferation marker changes
Absolute Ki67 change as well as geometric mean percentage change in Ki67 positivity
Measured: 4 years
pathologic complete response (pCR)
Disappearance of residual invasive disease (residual ductal carcinoma in situ allowed) in breast and the absence of positive lymph nodes
Measured: 4 years
pathological response rate
The proportion of patients achieving pathological response based on Miller-Payne grading system
Measured: 4 years
Progression-free survival (DFS)
The interval between the date of randomization to disease progression during treatment, any recurrence, contralateral breast cancer, the appearance of a second primary cancer, or death not due to cancer, whichever occurred first.
Measured: 6 years
Incidence of Serious Treatment-Emergent Adverse Events(grade 3 or 4)
Assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study startMay 2013
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhimin Shao, Fudan University
- Investigators
- Zhi-Min Shao, MD, Principal investigator, Cancer Hospital/ Institute, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02980965
- Sponsor's protocol ID
- NCET-trial
- Status last verified
- Nov 2017
- First submitted
- 26 Nov 2016
- Last updated
- 13 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study to Evaluate the Efficacy and Safety of Endocrine Therapy Plus Chemotherapy Versus Chemotherapy Alone as the Neoadjuvant Therapy in the Treatment of ER-positive, HER2-negative Breast Cancer (IIa-IIIc)
- ClinicalTrials.gov ID
- NCT02980965
- Acronym / sponsor ID
- NCET-trial
- Conditions
- Breast Cancer Female
- Keywords
- breast cancer, neoadjuvant chemotherapy, endocrine therapy, concurrent
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 2 Dec 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.
This was an open-label, randomized controlled trial that aims to compare the efficacy and safety of the concurrent neoadjuvant chemotherapy with endocrine therapy and neoadjuvant chemotherapy alone in ER-positive, HER2-negative breast cancer.
Detailed description
Data showed that concurrent neoadjuvant chemotherapy with endocrine therapy was a effective option for ER-positive, HER2-negative breast cancer patients. However this is still a controversial issue. The present study is an open-label randomized controlled clinical trial that aims to investigate the efficacy of concurrent NCT with endocrine therapy (AI with or without GnRH-a) in patients with ER-positive, HER2-negative breast carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neoadjuvant chemo-endocrine therapy | Experimental | Drug: letrozole, leuprorelin, fluorouracil, epirubicin, cyclophosphamide, docetaxelIn the experimental arm, patients received concurrent chemotherapy (fluorouracil 500mg/m2 IV, epirubicin 90mg/m2 IV and cyclophosphamide 500mg/m2 IV on day 1 at 3-weekly intervals for 3 cycles followed by docetaxel 100mg/m2 IV on day 1 at 3-weekly intervals for 3 cycles; or epirubicin 90mg/m2 IV and cyclophosphamide 600mg/m2 IV on day 1 at 2-weekly intervals for 4 cycles, followed by docetaxel 100mg/m2 IV on day 1 at 2-weekly intervals for 4 cycles) with endocrine therapy (letrozole with or without leuprorelin) as a neoadjuvant treatment |
| neoadjuvant chemotherapy alone | Active comparator | Drug: fluorouracil, epirubicin, cyclophosphamide, docetaxelIn the control group, patients received neoadjuvant chemotherapy alone (fluorouracil 500mg/m2 IV, epirubicin 90mg/m2 IV and cyclophosphamide 500mg/m2 IV on day 1 at 3-weekly intervals for 3 cycles followed by docetaxel 100mg/m2 IV on day 1 at 3-weekly intervals for 3 cycles; or epirubicin 90mg/m2 IV and cyclophosphamide 600mg/m2 IV on day 1 at 2-weekly intervals for 4 cycles, followed by docetaxel 100mg/m2 IV on day 1 at 2-weekly intervals for 4 cycles) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Estrogen receptor-positive and HER2-negative breast cancer patients, with histological stage of IIa-IIIc.
- Without previous chemotherapy or endocrine therapy.
- ECOG scores of 0-2 points
- With measurable and evaluable breast tumor pathologically confirmed as invasive ductal carcinoma
- Age: 18-70 years
Key exclusion criteria (11 listed)
- Pregnant women or nursing mothers
- With distant metastasis
- With a history of malignant tumor or complicated with other malignant tumors in addition to breast cancer, except for non-melanoma skin cancer, in situ cervical cancer or other cured malignant tumor without the basis of recurrence for at least five years
- With mental illness or other conditions affecting the patient compliance
- With other serious diseases or medical conditions:
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 |
|---|---|---|
| letrozole, leuprorelin, fluorouracil, epirubicin, cyclophosphamide, docetaxelAlso: GnRH-a, ENANTONEPostmenopausal patients were treated with letrozole 2.5mg/day p.o until complement of neoadjuvant chemotherapy before surgery, while premenopausal ones received letrozole 2.5mg/day p.o and a subcutaneous injection of the GnRH-a, leuprorelin, as concomitant treatment with neoadjuvant chemotherapy (fluorouracil 600mg/m2 IV, epirubicin 90mg/m2 IV and cyclophosphamide 600mg/m2 IV on day 1 at 3-weekly intervals for 3 cycles followed by docetaxel 100mg/m2 IV on day 1 at 3-weekly intervals for 3 cycles; or epirubicin 90mg/m2 IV and cyclophosphamide 600mg/m2 IV on day 1 at 2-weekly intervals for 4 cycles, followed by docetaxel 80mg/m2 IV on day 1 at 2-weekly intervals for 4 cycles), letrozole was delivered after 1 week of first dose of leuprorelin injection. | Drug | neoadjuvant chemo-endocrine therapy |
| fluorouracil, epirubicin, cyclophosphamide, docetaxelPatients received fluorouracil 500mg/m2 IV, epirubicin 90mg/m2 IV and cyclophosphamide 500mg/m2 IV on day 1 at 3-weekly intervals for 3 cycles followed by docetaxel 100mg/m2 IV on day 1 at 3-weekly intervals for 3 cycles; or epirubicin 90mg/m2 IV and cyclophosphamide 600mg/m2 IV on day 1 at 2-weekly intervals for 4 cycles, followed by docetaxel 100mg/m2 IV on day 1 at 2-weekly intervals for 4 cycles. | Drug | neoadjuvant chemotherapy alone |
Primary outcome
objective response rate (ORR)
Time frame: 4 years
the proportion of patients achieving clinical complete response and partial response in the breast based on magnetic resonance imaging
5 secondary outcomes
Ki67 proliferation marker changes
Time frame: 4 years
pathologic complete response (pCR)
Time frame: 4 years
pathological response rate
Time frame: 4 years
Progression-free survival (DFS)
Time frame: 6 years
Incidence of Serious Treatment-Emergent Adverse Events(grade 3 or 4)
Time frame: 4 years
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 13 Nov 2017.
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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.
Zhi-Min Shao, MD principal investigator
Cancer Hospital/ Institute, 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 3 study testing letrozole, leuprorelin, fluorouracil, epirubicin, cyclophosphamide, docetaxel and fluorouracil, epirubicin, cyclophosphamide, docetaxel in people with Breast Cancer Female, 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 7 inclusion and 11 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 13 Nov 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 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?
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?
objective response rate (ORR) (time frame: 4 years). 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 13 Nov 2017.