Breast CancerPhase 2NCT02041338
Study of Optimizing Neoadjuvant Regimens in Subtypes of Breast Cancer
A Phase 2 study testing Paclitaxel and carboplatin, Paclitaxel and Epirubicin and Paclitaxel in people with Breast Cancer and Neoadjuvant Chemotherapy, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
There are no standard neodjuvant regimens adapted according to the different subtypes of breast cancer. This is a phase 2, randomized study to evaluate several regimens in different subtypes of breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Neoadjuvant Chemotherapy
- What is being tested?
- Paclitaxel and carboplatin, Paclitaxel and Epirubicin and Paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Dec 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage IIa-IIIc breast cancer patients plan to receive neoadjuvant chemotherapy
- Patients have enough tissue sample to do IHC test for subtype classification
- Patients have at least one measurable lesion according to RECIST1.1
- KPS≥80
- No prior treatment for breast cancer
- Adequate bone marrow (neutrophil count ≥1500 ml and platelet count ≥100,000 ml), renal (serum creatinine <1.5 times the upper limit of normal [ULN] or a creatinine clearance of ≥60 ml/minute), hepatic (total bilirubin ≤1.5 ULN; alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase ≤2.5 ULN), and cardiac function (assessed by electrocardiogram or thoracic radiography) were required.
Who cannot join
- Fertile women were excluded if pregnant or lactating or if they were not using adequate contraception.
- Previous chemotherapy for breast cancer.
- history of other serious illness (e.g. congestive heart failure, angina pectoris, uncontrolled hypertension or arrhythmia, clinically significant neurologic or psychiatric disorders, uncontrolled serious infection, AIDS), had an organ allograft, severe gastrointestinal disorder, or other neoplasias (except for in situ cervical cancer, non-melanoma skin cancer, or previous diagnosis of cancer with no evidence of disease for >10 years).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, 100021
Ying Fan, MD, 861087788114, fanyingfy@medmail.com.cn
Xiang Wang, MD
About this study
Official title: Phase 2 Randomized Study of Different Neoadjuvant Regimens in Subtypes of Breast Cancer
There are no standard neodjuvant regimens adapted according to the different subtypes of breast cancer. This is a phase 2, randomized study to evaluate several regimens in different subtypes of breast cancer.
Read the detailed description
Breast cancer is a heterogenous disease with at least 4 intrinsic subtypes including Luminal A, Luminal B, HER2 enriched, Basal-like and normal breast like. Different subtypes have different prognosis and treatment sensitivity. Thus, it would be more suitable to administer different chemo-regimen in different subtypes. This is especially true in neoadjuvant chemotherapy setting where no standard regimen has ever been established. Therefore, we designed this phase 2 randomized clinical trial to explore potential effective regimens in variable subtypes of breast cancer in neoadjuvant treatment. Patients were first classified into Luminal type, Her2 positive type and triple-negative type by immunohistochemistry exam of ER/PR/HER2 in core needle biopsy and then randomized to received either dose dense paclitaxel in Luminal type or dose dense paclitaxel plus carboplatin with or without trastuzumab in HER2 positive type or dose dense paclitaxel plus carboplatin in triple-negative type.The control groups in each subtype all receive paclitaxel plus epirubicin every 3 weeks. The duration of treatment is 4-6 cycles. Primary endpoint is the pathological CR rate in each subtypes. Secondary endpoints include disease free survival, objective response rate, safety. Tissue samples and blood samples will be collected at baseline and during treatment. There will be exploratory biomarkers analyses to identify predictive markers for efficacy in every subtypes.
- Conditions
- Breast Cancer, Neoadjuvant Chemotherapy
- Being tested
- Paclitaxel and carboplatin, Paclitaxel, Epirubicin and Paclitaxel
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel and carboplatinDrug
PaclitaxelDrug
Epirubicin and PaclitaxelDrug
| Study group | Role | What they receive |
|---|---|---|
| Luminal subtype test | Experimental | Paclitaxel 175mg/m2, every 2 weeks as a cycle for 4-6 cycles Receives: Drug: Paclitaxel |
| Luminal subtype control | Active comparator | Epirubicin 75mg/m2 plus paclitaxel 175mg/m2 every 3 weeks as a cycle for 4-6 cycles Receives: Drug: Epirubicin and Paclitaxel |
| Her2 positive subtype test | Experimental | Paclitaxel 175mg/m2 plus carboplatin AUC 4 with or without trastuzumab every 2 weeks as a cycle for 4-6 cycles Receives: Drug: Paclitaxel and carboplatin |
| Her2 positive subtype control | Active comparator | Epirubicin 75mg/m2 plus paclitaxel 175mg/m2 with or without trastuzumab every 3 weeks as a cycle for 4-6 cycles Receives: Drug: Epirubicin and Paclitaxel |
| Triple negative subtype test | Experimental | Paclitaxel 175mg/m2 plus carboplatin AUC 4 every 2 weeks as a cycle for 4-6 cycles Receives: Drug: Paclitaxel and carboplatin |
| Triple negative subypte control | Active comparator | Epirubicin 75mg/m2 plus paclitaxel 175mg/m2 every 3 weeks as a cycle for 4-6 cycles Receives: Drug: Epirubicin and Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathological complete response(pCR) rate of breast and axilla after surgery
pathological complete response(pCR) of breast and axilla after surgery means after operation, no invasive component can be found in both breast and axillary lymph nodes. The pCR rate is calculated by number of patients having pCR after sugery divided by number of patients receiving neoadjuvant chemotherapy.
Measured: 3 years
Secondary outcomes (3)
Disease free survival
Measured: 3years and 5years after operation
Overall survival
Measured: 3 years and 5years after operation
Adverse event
Measured: during screening and treatment, withing 21 days after day 1 of last cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 200 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
- Binghe Xu, MD, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02041338
- Sponsor's protocol ID
- CH-BC-026
- Status last verified
- Feb 2014
- First submitted
- 15 Jan 2014
- Last updated
- 25 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Randomized Study of Different Neoadjuvant Regimens in Subtypes of Breast Cancer
- ClinicalTrials.gov ID
- NCT02041338
- Acronym / sponsor ID
- CH-BC-026
- Conditions
- Breast Cancer, Neoadjuvant Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 22 Jan 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.
There are no standard neodjuvant regimens adapted according to the different subtypes of breast cancer. This is a phase 2, randomized study to evaluate several regimens in different subtypes of breast cancer.
Detailed description
Breast cancer is a heterogenous disease with at least 4 intrinsic subtypes including Luminal A, Luminal B, HER2 enriched, Basal-like and normal breast like. Different subtypes have different prognosis and treatment sensitivity. Thus, it would be more suitable to administer different chemo-regimen in different subtypes. This is especially true in neoadjuvant chemotherapy setting where no standard regimen has ever been established. Therefore, we designed this phase 2 randomized clinical trial to explore potential effective regimens in variable subtypes of breast cancer in neoadjuvant treatment. Patients were first classified into Luminal type, Her2 positive type and triple-negative type by immunohistochemistry exam of ER/PR/HER2 in core needle biopsy and then randomized to received either dose dense paclitaxel in Luminal type or dose dense paclitaxel plus carboplatin with or without trastuzumab in HER2 positive type or dose dense paclitaxel plus carboplatin in triple-negative type.The control groups in each subtype all receive paclitaxel plus epirubicin every 3 weeks. The duration of treatment is 4-6 cycles. Primary endpoint is the pathological CR rate in each subtypes. Secondary endpoints include disease free survival, objective response rate, safety. Tissue samples and blood samples will be collected at baseline and during treatment. There will be exploratory biomarkers analyses to identify predictive markers for efficacy in every subtypes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Luminal subtype test | Experimental | Drug: PaclitaxelPaclitaxel 175mg/m2, every 2 weeks as a cycle for 4-6 cycles |
| Luminal subtype control | Active comparator | Drug: Epirubicin and PaclitaxelEpirubicin 75mg/m2 plus paclitaxel 175mg/m2 every 3 weeks as a cycle for 4-6 cycles |
| Her2 positive subtype test | Experimental | Drug: Paclitaxel and carboplatinPaclitaxel 175mg/m2 plus carboplatin AUC 4 with or without trastuzumab every 2 weeks as a cycle for 4-6 cycles |
| Her2 positive subtype control | Active comparator | Drug: Epirubicin and PaclitaxelEpirubicin 75mg/m2 plus paclitaxel 175mg/m2 with or without trastuzumab every 3 weeks as a cycle for 4-6 cycles |
| Triple negative subtype test | Experimental | Drug: Paclitaxel and carboplatinPaclitaxel 175mg/m2 plus carboplatin AUC 4 every 2 weeks as a cycle for 4-6 cycles |
| Triple negative subypte control | Active comparator | Drug: Epirubicin and PaclitaxelEpirubicin 75mg/m2 plus paclitaxel 175mg/m2 every 3 weeks as a cycle for 4-6 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Stage IIa-IIIc breast cancer patients plan to receive neoadjuvant chemotherapy
- Patients have enough tissue sample to do IHC test for subtype classification
- Patients have at least one measurable lesion according to RECIST1.1
- KPS≥80
- No prior treatment for breast cancer
Key exclusion criteria (3 listed)
- Fertile women were excluded if pregnant or lactating or if they were not using adequate contraception.
- Previous chemotherapy for breast cancer.
- history of other serious illness (e.g. congestive heart failure, angina pectoris, uncontrolled hypertension or arrhythmia, clinically significant neurologic or psychiatric disorders, uncontrolled serious infection, AIDS), had an organ allograft, severe gastrointestinal disorder, or other neoplasias (except for in situ cervical cancer, non-melanoma skin cancer, or previous diagnosis of cancer with no evidence of disease for >10 years).
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 and carboplatin | Drug | Her2 positive subtype test, Triple negative subtype test |
| Paclitaxel | Drug | Luminal subtype test |
| Epirubicin and Paclitaxel | Drug | Her2 positive subtype control, Luminal subtype control, Triple negative subypte control |
Primary outcome
pathological complete response(pCR) rate of breast and axilla after surgery
Time frame: 3 years
pathological complete response(pCR) of breast and axilla after surgery means after operation, no invasive component can be found in both breast and axillary lymph nodes. The pCR rate is calculated by number of patients having pCR after sugery divided by number of patients receiving neoadjuvant chemotherapy.
3 secondary outcomes
Disease free survival
Time frame: 3years and 5years after operation
Overall survival
Time frame: 3 years and 5years after operation
Adverse event
Time frame: during screening and treatment, withing 21 days after day 1 of last cycle
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2014.
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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.
Binghe Xu, MD principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
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 and carboplatin, Paclitaxel and Epirubicin and Paclitaxel in people with Breast Cancer and Neoadjuvant Chemotherapy, 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 6 inclusion and 3 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 25 Nov 2014. 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 Ying Fan, MD (861087788114, fanyingfy@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathological complete response(pCR) rate of breast and axilla after surgery (time frame: 3 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 25 Nov 2014.