Breast Cancer Nos PremenopausalNCT01503905
Neoadjuvant Chemotherapy for Operable Premenopausal Breast Cancer Patients
A study testing Docetaxel, epirubicin and cyclophosphamide in people with Breast Cancer Nos Premenopausal, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 17 sites in China.
Trial summary
The current study is a multicentre, randomized, open (unblended), prospective clinical trial which is sponsored by the researchers. The trial is designed to compare the effectiveness between docetaxel plus epirubicin, and docetaxel plus epirubicin plus cyclophosphamide as neoadjuvant chemotherapy for operable… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Nos Premenopausal
- What is being tested?
- Docetaxel, epirubicin and cyclophosphamide
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 17 sitesChina
- Study dates
- Dec 2011to Dec 2021
- Phase
- Interventional
- 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
- The patients signed the written informed consent.
- The patients present with operable breast cancers that were diagnosed by histopathology and have no distant metastasis.
- The patients have no history of anti-cancer therapies including chemotherapy, radiation therapy, hormone therapy and surgical therapy.
- The patients have normal cardiac functions by echocardiography.
- The patients' ECOG scores are ≤ 0-2.
- The age of patient is ≥ 18 years old; And the patients are premenopausal females.
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- The patients are disposed to practice contraception during the whole trial.
- The results of patients' blood tests are as follows:
- Hb ≥ 90 g/L
- WBC ≥ 4.0×109/L
- Plt ≥ 100×109/L
- Neutrophils ≥ 1.5×109/L
- ALT and AST ≤ triple of normal upper limit.
- TBIL ≤ 1.5 times of normal upper limit.
- Creatinine ≤ 1.25 times of normal upper limit.
Who cannot join
- The patients have other cancers at the same time or have the history of other cancers in recent five years, excluding the controlled skin basal cell carcinoma or skin squamous cell carcinoma or carcinoma in situ of cervix.
- The patients have active infections that were not suitable for chemotherapy.
- The patients have severe non-cancerous diseases.
- The patients are undergoing current administration of anti-cancer therapies, or are attending some other clinical trails.
- The patients whose breast cancers are HER2 positive and choose to undergo the neoadjuvant chemotherapy that includes herceptin regimen.
- The patients are pregnant or lactational, or they refuse to practice contraception during the whole trial.
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- The patients are in some special conditions that they can't understand the written informed consent, such as they are demented or hawkish.
- The patients have allergic history of the chemotherapeutic agents.
- The patients have bilateral breast cancers.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
China17 sites, 17 recruiting
- Recruiting
The first People's Hospital of Foshan
Foshan, Guangdong, 528000
Jie Yang, 86-13902805191
- Recruiting
Guangdong Women and Children Hospital
Guangzhou, Guangdong, 510010
Antai Zhang, 86-13925115929
- Recruiting
Guangzhou Army General Hospital
Guangzhou, Guangdong, 510010
Chenfang Zhang, 86-13889908978
- Recruiting
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060
Siyu Wang, 86-18688464714
- Recruiting
The First Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510080
Zhuanghong Wu, 86-13602722502
- Recruiting
Tumor Hospital of Guangzhou
Guangzhou, Guangdong, 510095
Hongsheng Li, 86-13725111258
- Recruiting
The Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
Guangzhou, Guangdong, 510100
Pengxi Liu, 86-13560333752
- Recruiting
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510120
Fengxi Su, fengxisu@vip.163.com
- Recruiting
Guangzhou Women and Children Hospital
Guangzhou, Guangdong, 510180
Hongmin Ma, 86-13922723808
- Recruiting
The first People's Hospital of Guangzhou
Guangzhou, Guangdong, 510180
Li Zhao, gdzhaoli@163.com
- Recruiting
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510260
Lehong Zhang, 86-13719150959
- Recruiting
Zhujiang Hospital of Nanfang Medical University
Guangzhou, Guangdong, 510282
Aiguo Wu, wagtyz@sina.com
- Recruiting
Nanfang Hospital of Nanfang Medical University
Guangzhou, Guangdong, 510515
Changsheng Ye, 86-13802954097
- Recruiting
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, 510630
Ningxia Wang, Twnx@Jnu.edu.cn
- Recruiting
The Third Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510630
Renbin Liu, 86-13570073298
- Recruiting
Shenzhen People's Hospital
Shenzhen, Guangdong, 518020
Dongxian Zhou, 86-13510363636
- Recruiting
The first Affiliated Hospital of Shenzhen University
Shenzhen, Guangdong, 518035
Xianming Wang, 86-13500056238
About this study
Official title: Comparison of the Effectiveness of Neoadjuvant Chemotherapy and the Outcomes Associated With Chemo-induced Amenorrhea Between Docetaxel Plus Epirubicin, and Docetaxel Plus Epirubicin Plus Cyclophosphamide as Neoadjuvant Chemotherapy for Operable Premenopausal Breast Cancer Patients.
The current study is a multicentre, randomized, open (unblended), prospective clinical trial which is sponsored by the researchers. The trial is designed to compare the effectiveness between docetaxel plus epirubicin, and docetaxel plus epirubicin plus cyclophosphamide as neoadjuvant chemotherapy for operable premenopausal breast cancer patients, and also to compare the outcomes associated with chemo-induced amenorrhea between the two neoadjuvant chemotherapies. The investigators will randomly assign 600 premenopausal female patients with operable breast cancer to receive four cycles of docetaxel and epirubicin (TE); or four cycles of docetaxel, epirubicin, and cyclophosphamide (TEC). After every two cycles of neoadjuvant chemotherapy, the investigators will estimate the effectiveness of therapy. Patients will undergo modified radical mastectomy or breast-conserving surgery after four cycles of neoadjuvant chemotherapy, and then receive postoperative chemotherapy (two cycles), radiation therapy, herceptin targeted therapy or hormone therapy according to the NCCN (2011) guideline. The follow-up will be ten years after surgeries. The primary aim is to examine whether the docetaxel and epirubicin (TE) will be as effective as the docetaxel, epirubicin, and cyclophosphamide (TEC) (pCR rate, cCR rate, PR rate, SD rate, progression-free survival (PFS) and overall survival (OS)). The secondary aim is to correlate chemo (TE/TEC)-induced amenorrhea with outcomes in premenopausal women.
- Conditions
- Breast Cancer Nos Premenopausal
- Being tested
- Docetaxel, epirubicin, cyclophosphamide, Modified radical mastectomy or breast-conserving Surgery, Docetaxel (post-operative)
- Keywords
- breast cancer, neoadjuvant chemotherapy, amenorrhea
- Medical subject headings
- Breast Neoplasms, Amenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
75mg/m2, iv injection, day1, every 21 days
epirubicinDrug
80mg/ m2, iv injection, day1, every 21 days
cyclophosphamideDrug
500 mg/m2, iv injection, day1, every 21 days
Modified radical mastectomy or breast-conserving SurgeryProcedure or surgery
Two weeks after four cycles of neoadjuvant chemotherapy
Docetaxel (post-operative)Drug
Two weeks after surgery,75mg/m2, iv injection, day1, every 21 days, 4 cycles totally.
Epirubicin (post-operative)Drug
Two weeks after surgery, 80mg/m2,iv injection, day1, every 21 days, 4 cycles totally
Cyclophosphamide (post-operative)Drug
Two weeks after surgery, 500mg/m2, iv injection, day1, every 21 days, 4 cycles totally.
Radiation therapyRadiation
Two weeks after post-operative chemotherapy, perform radiation therapy based on 2011 NCCN guideline.
Herceptin （post-operative)Drug
Perform herceptin therapy (one year) based on 2011 NCCN guideline if the pathological test of the operative tumor sample showed HER2 positive.
Tamoxifen (post-operative)Drug
After radiation therapy, totally five years. Perform hormone therapy based on 2011 NCCN guideline if the tumor is ER/PR positive.
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel plus epirubicin | Active comparator | Not described Receives: Drug: Docetaxel; Drug: epirubicin; Procedure: Modified radical mastectomy or breast-conserving Surgery; Drug: Docetaxel (post-operative); Drug: Epirubicin (post-operative); Radiation: Radiation therapy; Drug: Herceptin （post-operative); Drug: Tamoxifen (post-operative) |
| docetaxel plus epirubicin plus cyclophosphamide | Active comparator | Not described Receives: Drug: Docetaxel; Drug: epirubicin; Drug: cyclophosphamide; Procedure: Modified radical mastectomy or breast-conserving Surgery; Drug: Docetaxel (post-operative); Drug: Epirubicin (post-operative); Drug: Cyclophosphamide (post-operative); Radiation: Radiation therapy; Drug: Herceptin （post-operative); Drug: Tamoxifen (post-operative) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival of patients.
Measured: within 10 years after diagnosis
Overall survival of the patients
Measured: within 10 years after diagnosis
Secondary outcomes (2)
The pathological remission rate of patients after neoadjuvant chemotherapy.
Measured: within 80 days after diagnosis (after 4 cycles of neoadjuvant chemotherapy)
The clinical remission rate of patients after neoadjuvant chemotherapy
Measured: within 80 days after diagnosis (after 4 cycles of neoadjuvant chemotherapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionMay 2018 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Nos PremenopausalStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fengxi Su, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Investigators
- Fengxi Su, M.D., Study chair, Sun Yat-Sen Memerial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01503905
- Sponsor's protocol ID
- BCSCO001
- Status last verified
- May 2016
- First submitted
- 29 Dec 2011
- Last updated
- 24 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Neoadjuvant Chemotherapy and the Outcomes Associated With Chemo-induced Amenorrhea Between Docetaxel Plus Epirubicin, and Docetaxel Plus Epirubicin Plus Cyclophosphamide as Neoadjuvant Chemotherapy for Operable Premenopausal Breast Cancer Patients.
- ClinicalTrials.gov ID
- NCT01503905
- Acronym / sponsor ID
- BCSCO001
- Conditions
- Breast Cancer Nos Premenopausal
- Keywords
- breast cancer, neoadjuvant chemotherapy, amenorrhea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- May 2018 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 4 Jan 2012 (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.
The current study is a multicentre, randomized, open (unblended), prospective clinical trial which is sponsored by the researchers. The trial is designed to compare the effectiveness between docetaxel plus epirubicin, and docetaxel plus epirubicin plus cyclophosphamide as neoadjuvant chemotherapy for operable premenopausal breast cancer patients, and also to compare the outcomes associated with chemo-induced amenorrhea between the two neoadjuvant chemotherapies. The investigators will randomly assign 600 premenopausal female patients with operable breast cancer to receive four cycles of docetaxel and epirubicin (TE); or four cycles of docetaxel, epirubicin, and cyclophosphamide (TEC). After every two cycles of neoadjuvant chemotherapy, the investigators will estimate the effectiveness of therapy. Patients will undergo modified radical mastectomy or breast-conserving surgery after four cycles of neoadjuvant chemotherapy, and then receive postoperative chemotherapy (two cycles), radiation therapy, herceptin targeted therapy or hormone therapy according to the NCCN (2011) guideline. The follow-up will be ten years after surgeries. The primary aim is to examine whether the docetaxel and epirubicin (TE) will be as effective as the docetaxel, epirubicin, and cyclophosphamide (TEC) (pCR rate, cCR rate, PR rate, SD rate, progression-free survival (PFS) and overall survival (OS)). The secondary aim is to correlate chemo (TE/TEC)-induced amenorrhea with outcomes in premenopausal women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Docetaxel plus epirubicin | Active comparator | Drug: Docetaxel, Drug: epirubicin, Procedure: Modified radical mastectomy or breast-conserving Surgery, Drug: Docetaxel (post-operative), Drug: Epirubicin (post-operative), Radiation: Radiation therapy, Drug: Herceptin （post-operative), Drug: Tamoxifen (post-operative) |
| docetaxel plus epirubicin plus cyclophosphamide | Active comparator | Drug: Docetaxel, Drug: epirubicin, Drug: cyclophosphamide, Procedure: Modified radical mastectomy or breast-conserving Surgery, Drug: Docetaxel (post-operative), Drug: Epirubicin (post-operative), Drug: Cyclophosphamide (post-operative), Radiation: Radiation therapy, Drug: Herceptin （post-operative), Drug: Tamoxifen (post-operative) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- The patients signed the written informed consent.
- The patients present with operable breast cancers that were diagnosed by histopathology and have no distant metastasis.
- The patients have no history of anti-cancer therapies including chemotherapy, radiation therapy, hormone therapy and surgical therapy.
- The patients have normal cardiac functions by echocardiography.
- The patients' ECOG scores are ≤ 0-2.
Key exclusion criteria (9 listed)
- The patients have other cancers at the same time or have the history of other cancers in recent five years, excluding the controlled skin basal cell carcinoma or skin squamous cell carcinoma or carcinoma in situ of cervix.
- The patients have active infections that were not suitable for chemotherapy.
- The patients have severe non-cancerous diseases.
- The patients are undergoing current administration of anti-cancer therapies, or are attending some other clinical trails.
- The patients whose breast cancers are HER2 positive and choose to undergo the neoadjuvant chemotherapy that includes herceptin regimen.
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 |
|---|---|---|
| Docetaxel75mg/m2, iv injection, day1, every 21 days | Drug | Docetaxel plus epirubicin, docetaxel plus epirubicin plus cyclophosphamide |
| epirubicin80mg/ m2, iv injection, day1, every 21 days | Drug | Docetaxel plus epirubicin, docetaxel plus epirubicin plus cyclophosphamide |
| cyclophosphamide500 mg/m2, iv injection, day1, every 21 days | Drug | docetaxel plus epirubicin plus cyclophosphamide |
| Modified radical mastectomy or breast-conserving SurgeryTwo weeks after four cycles of neoadjuvant chemotherapy | Procedure or surgery | Docetaxel plus epirubicin, docetaxel plus epirubicin plus cyclophosphamide |
| Docetaxel (post-operative)Two weeks after surgery,75mg/m2, iv injection, day1, every 21 days, 4 cycles totally. | Drug | Docetaxel plus epirubicin, docetaxel plus epirubicin plus cyclophosphamide |
| Epirubicin (post-operative)Two weeks after surgery, 80mg/m2,iv injection, day1, every 21 days, 4 cycles totally | Drug | Docetaxel plus epirubicin, docetaxel plus epirubicin plus cyclophosphamide |
| Cyclophosphamide (post-operative)Two weeks after surgery, 500mg/m2, iv injection, day1, every 21 days, 4 cycles totally. | Drug | docetaxel plus epirubicin plus cyclophosphamide |
| Radiation therapyTwo weeks after post-operative chemotherapy, perform radiation therapy based on 2011 NCCN guideline. | Radiation | Docetaxel plus epirubicin, docetaxel plus epirubicin plus cyclophosphamide |
| Herceptin （post-operative)Perform herceptin therapy (one year) based on 2011 NCCN guideline if the pathological test of the operative tumor sample showed HER2 positive. | Drug | Docetaxel plus epirubicin, docetaxel plus epirubicin plus cyclophosphamide |
| Tamoxifen (post-operative)After radiation therapy, totally five years. Perform hormone therapy based on 2011 NCCN guideline if the tumor is ER/PR positive. | Drug | Docetaxel plus epirubicin, docetaxel plus epirubicin plus cyclophosphamide |
Primary outcome
Progression-free survival of patients.
Time frame: within 10 years after diagnosis
Overall survival of the patients
Time frame: within 10 years after diagnosis
2 secondary outcomes
The pathological remission rate of patients after neoadjuvant chemotherapy.
Time frame: within 80 days after diagnosis (after 4 cycles of neoadjuvant chemotherapy)
The clinical remission rate of patients after neoadjuvant chemotherapy
Time frame: within 80 days after diagnosis (after 4 cycles of neoadjuvant chemotherapy)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2016.
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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.
Fengxi Su, M.D. study chair
Sun Yat-Sen Memerial Hospital of Sun Yat-Sen University
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Docetaxel, epirubicin and cyclophosphamide in people with Breast Cancer Nos Premenopausal, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 17 sites 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 15 inclusion and 9 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 24 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites 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.
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 Fengxi Su, M.D. (86-20-34071156, fengxisu@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival of patients. (time frame: within 10 years after diagnosis). 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 24 May 2016.