Triple Negative Breast CancerPhase 2NCT01276769
Comparison Study of Neoadjuvant Paclitaxel Plus Carboplatin/Epirubicin Treatment in Triple-negative Breast Cancer
A Phase 2 study testing Paclitaxel plus carboplatin and Paclitaxel and epirubicin in people with Triple Negative Breast Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This study is to compare the effective of Paclitaxel combined with Epirubicin and Paclitaxel plus Carboplatin in the neoadjuvant treatment for TNBC. And the investigators hypothesized that paclitaxel combined with carboplatin is more sensitive to TNBC compared with Paclitaxel plus Epirubicin,this study will also have… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Triple Negative Breast Cancer
- What is being tested?
- Paclitaxel plus carboplatin and Paclitaxel and epirubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Jan 2008to Jul 2012
- 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
- Women aged from 18 to 70 years;
- WHO Performance status (ECOG) of 0 or 1
- Core biopsy histologically proven Ⅱa-Ⅲc phase breast cancer (regardless of the type);
- Immunohistochemisty（IHC）：ER-，PR-，CerB2-；Triple negative （ER-PR-Her-2-） Hormone receptor negativity is defined as ER<10%, PR<10% (IHC), HER2 negativity is defined as IHC 0-1+, or [IHC 2+ and FISH or CISH negative]；
- Adequate hematological function (neutrophil count ³ 2x109/l, platelet count ³ 100x 109/l, Hemoglobin > 9 g/dl);
- Adequate hepatic function: ASAT and ALAT £ 1.5 ULN alkaline phosphatases £ 2.5 ULN,total bilirubin £ 1,5 ULN;
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- Adequate renal function: serum creatinine £ 1.5 ULN;
- Adequate cardiac function, LEVF value > 50% by Muga scan or echocardiography，and electrocardiogram doe not show specific abnormality；
- Patients accepting contraception intake during the overall length of treatment if of childbearing potential;
- Signed written informed consent.
Who cannot join
- Any tumor ³ T4a (UICC1987) (cutaneous invasion, deep adherence, inflammatory breast cancer);
- ER+ or PR+ or Her-2 overexpression
- Any chemotherapy, hormonal therapy or radiotherapy before
- Previous cancer in the preceding 10 years;
- Patients already included in another therapeutic trial involving an experimental drug;
- Patients with other concurrent severe and/or uncontrolled medical disease or infection which could compromise participation in the study;
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- LEVF < 50% (MUGA scan or echocardiography);
- Clinically significant cardiovascular disease (e.g. unstable angina, congestive heart failure, uncontrolled hypertension (>150/90), myocardial infarction or cerebral vascular accidents) within 6 months prior to chemotherapy;
- Known prior severe hypersensitivity reactions to agents that will be received;
- Women who are pregnant or breastfeeding. Adequate birth control measures should be taken during study treatment phase;
- Women with a positive pregnancy test en enrollment or prior to study drug administration;
- Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial;
- Individual deprived of liberty or placed under the authority of a tutor.
Trial locations and contacts
1 site in 1 country.
YIN Yi, BD contact
China1 site, 1 recruiting
- Recruiting
Cancer institute &Hospital，Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
ZHANG Pin, BD, +861087788120, zhang_pin@163.com
YIN Yi, BD, elovf1@163.com
About this study
Official title: Phase IIb Trial of Paclitaxel Plus Carboplatin Versus Paclitaxel Plus Epirubicin as Neoadjuvant Treatment in Locally Advanced Triple-negative Breast Cancer
This study is to compare the effective of Paclitaxel combined with Epirubicin and Paclitaxel plus Carboplatin in the neoadjuvant treatment for TNBC. And the investigators hypothesized that paclitaxel combined with carboplatin is more sensitive to TNBC compared with Paclitaxel plus Epirubicin,this study will also have a look into the relation of BRCA1 mutation and sensitive to carboplatin.
Read the detailed description
It is know that triple-negative breast cancer(TNBC) is more aggressive than non-triple negative breast cancer in both pathological features and clinical prognosis,and there is no standard chemotherapy regimens especially for TNBC. NCCN guidelines recommends Paclitaxel or Epirubicin based regimens as the preferred regimens both for the adjuvant chemotherapy and the treatment of Recurrence and Metastatic breast cancer.The combination of these two drugs is considered as a strong arrangement and therefore,is common used in Triple negative breast cancer patients because of its poor prognosis.
According to the results of some retrospective studies, platinum-based chemotherapy regimens showed a promising sensitive to Triple negative breast cancer patients compared with regimens without platinum.
This study is to compare the effective of Paclitaxel combined with Epirubicin and Paclitaxel plus Carboplatin in the neoadjuvant treatment for TNBC. And the investigators hypothesized that paclitaxel combined with carboplatin is more sensitive to TNBC compared with Paclitaxel plus Epirubicin,this study will also have a look into the relation of BRCA1 mutation and sensitive to carboplatin.
- Conditions
- Triple Negative Breast Cancer
- Being tested
- Paclitaxel plus carboplatin, Paclitaxel and epirubicin
- Keywords
- Triple Negative Breast Cancer, Neoadjuvant chemotherapy, Platinum
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel plus carboplatinDrug
Paclitaxel 175 mg/m2 D1 i.v., carboplatin AUC=5 D2 i.v.
1 cycle = 21days 2-6cycles
Paclitaxel and epirubicinDrug
Paclitaxel 175 mg/m2 D3 i.v.,Epirubicin 75mg/m2 D1，2 i.v.
1 cycle = 21days
2-6cycles
| Study group | Role | What they receive |
|---|---|---|
| ET | Active comparator | The control arm receive the paclitaxel plus epirubicin Receives: Drug: Paclitaxel and epirubicin |
| PC | Experimental | the experimental arm which receive the paclitaxel combined with carboplatin Receives: Drug: Paclitaxel plus carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathology of specimens derived from the breast modified radical mastectomy/Breast-conserving surgery
After patients complete the neoadjuvant chemothreapy and receive the surguries,we can get their pathology ，and compare the pCR（pathological complete remission）rates of two amrs
Measured: One week after the surgery
Secondary outcomes (1)
follow-up the patient every 3-6 months to obtain the 3 year-DFS(disease free survival ) and OS(overall survival )
Measured: we follow up the patients every 6 month ,up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2011 (estimated)
- Study startJan 2008
- Primary completionJul 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZHANG Pin, Chinese Academy of Medical Sciences
- Investigators
- ZHANG Pin, BD, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01276769
- Sponsor's protocol ID
- LC2010A03
- Status last verified
- Nov 2011
- First submitted
- 10 Dec 2010
- Last updated
- 16 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIb Trial of Paclitaxel Plus Carboplatin Versus Paclitaxel Plus Epirubicin as Neoadjuvant Treatment in Locally Advanced Triple-negative Breast Cancer
- ClinicalTrials.gov ID
- NCT01276769
- Acronym / sponsor ID
- LC2010A03
- Conditions
- Triple Negative Breast Cancer
- Keywords
- Triple Negative Breast Cancer, Neoadjuvant chemotherapy, Platinum
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 13 Jan 2011 (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 study is to compare the effective of Paclitaxel combined with Epirubicin and Paclitaxel plus Carboplatin in the neoadjuvant treatment for TNBC. And the investigators hypothesized that paclitaxel combined with carboplatin is more sensitive to TNBC compared with Paclitaxel plus Epirubicin,this study will also have a look into the relation of BRCA1 mutation and sensitive to carboplatin.
Detailed description
It is know that triple-negative breast cancer(TNBC) is more aggressive than non-triple negative breast cancer in both pathological features and clinical prognosis,and there is no standard chemotherapy regimens especially for TNBC. NCCN guidelines recommends Paclitaxel or Epirubicin based regimens as the preferred regimens both for the adjuvant chemotherapy and the treatment of Recurrence and Metastatic breast cancer.The combination of these two drugs is considered as a strong arrangement and therefore,is common used in Triple negative breast cancer patients because of its poor prognosis.
According to the results of some retrospective studies, platinum-based chemotherapy regimens showed a promising sensitive to Triple negative breast cancer patients compared with regimens without platinum.
This study is to compare the effective of Paclitaxel combined with Epirubicin and Paclitaxel plus Carboplatin in the neoadjuvant treatment for TNBC. And the investigators hypothesized that paclitaxel combined with carboplatin is more sensitive to TNBC compared with Paclitaxel plus Epirubicin,this study will also have a look into the relation of BRCA1 mutation and sensitive to carboplatin.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ET | Active comparator | Drug: Paclitaxel and epirubicinThe control arm receive the paclitaxel plus epirubicin |
| PC | Experimental | Drug: Paclitaxel plus carboplatinthe experimental arm which receive the paclitaxel combined with carboplatin |
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)
- Women aged from 18 to 70 years;
- WHO Performance status (ECOG) of 0 or 1
- Core biopsy histologically proven Ⅱa-Ⅲc phase breast cancer (regardless of the type);
- Immunohistochemisty（IHC）：ER-，PR-，CerB2-；Triple negative （ER-PR-Her-2-） Hormone receptor negativity is defined as ER<10%, PR<10% (IHC), HER2 negativity is defined as IHC 0-1+, or [IHC 2+ and FISH or CISH negative]；
- Adequate hematological function (neutrophil count ³ 2x109/l, platelet count ³ 100x 109/l, Hemoglobin > 9 g/dl);
Key exclusion criteria (13 listed)
- Any tumor ³ T4a (UICC1987) (cutaneous invasion, deep adherence, inflammatory breast cancer);
- ER+ or PR+ or Her-2 overexpression
- Any chemotherapy, hormonal therapy or radiotherapy before
- Previous cancer in the preceding 10 years;
- Patients already included in another therapeutic trial involving an experimental drug;
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 |
|---|---|---|
| Paclitaxel plus carboplatinPaclitaxel 175 mg/m2 D1 i.v., carboplatin AUC=5 D2 i.v. 1 cycle = 21days 2-6cycles | Drug | PC |
| Paclitaxel and epirubicinPaclitaxel 175 mg/m2 D3 i.v.,Epirubicin 75mg/m2 D1，2 i.v. 1 cycle = 21days 2-6cycles | Drug | ET |
Primary outcome
Pathology of specimens derived from the breast modified radical mastectomy/Breast-conserving surgery
Time frame: One week after the surgery
After patients complete the neoadjuvant chemothreapy and receive the surguries,we can get their pathology ，and compare the pCR（pathological complete remission）rates of two amrs
1 secondary outcome
follow-up the patient every 3-6 months to obtain the 3 year-DFS(disease free survival ) and OS(overall survival )
Time frame: we follow up the patients every 6 month ,up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2011.
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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.
YIN Yi, BD contact
ZHANG Pin, BD principal investigator
Cancer Institute and Hospital, 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 Paclitaxel plus carboplatin and Paclitaxel and epirubicin in people with Triple Negative 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 10 inclusion and 13 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 16 Nov 2011. 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 ZHANG Pin, BD (+861087788120, zhang_pin@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathology of specimens derived from the breast modified radical mastectomy/Breast-conserving surgery (time frame: One week after the surgery). 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 16 Nov 2011; AzTrials last refreshed its copy on 7 Nov 2026.