Breast CancerPhase 2NCT02934828
Study of Preoperative Chemotherapy for Early Triple Negative or HER2-positive Operable Breast Cancer
A Phase 2 study testing Neoadjuvant Chemotherapy and postoperative chemotherapy in people with Breast Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The investigators research aim to explores the optimal comprehensive treatment for TNBC and her2 positive breast cancer by comparing the efficacy of neoadjuvant with that of adjuvant treatment in improvement of RFS. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Neoadjuvant Chemotherapy and postoperative chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to Dec 2018
- 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
- Invasive breast cancer confirmed by pathology evaluation of core biopsy
- Tumors must be ER/PgR status negative (immunohistochemistry（IHC） < 10%) and lack of HER2/neu overexpression or amplification as measured by local hospital pathology laboratory (IHC +/- fluorescence in situ hybridization (FISH) and IHC < 3+, and FISH < 2.2) as described in the NCCN Guidelines
- Female between18 to 70 years of age, Eastern Cooperative Oncology Group(ECOG) Performance Status 0 or 1
- Early-stage TNBC or HER2 positive breast cancer according to the American Joint Committee on Cancer (AJCC) Staging Manual Clinical Stage IIA or IIB, Stage IIIA operable breast cancer
- Previously untreated
- Adequate hematologic function (absolute neutrophil count ≥ 1,500 cells/µL; hemoglobin > 9 g/dL, platelets > 100,000/µL.)
- Adequate hepatic function: total bilirubin ≤ upper limit of normal (ULN), serum albumin ≥≥ 3.0 g/dL, alanine aminotransferase and aspartate aminotransferase ≤ 1.5 x ULN.
Who cannot join
- ICH:ER/PgR status positive
- HER2 positive breast cancer Patients with reduced ejection fraction <50% are not eligible
- Patients with second malignancies
- Patients with bilateral breast cancer
- allergic constitution
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital & Institute Chinese Academy of Medical Sciences (CAMS)
Beijing, Beijing Municipality, 100021
Pin ZHang, professor, 13701275563, Zhang_pin@sina.com
About this study
Official title: A Randomized Study of Preoperative Chemotherapy or Postoperative Chemotherapy for Early Triple Negative or Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Operable Breast Cancer
The investigators research aim to explores the optimal comprehensive treatment for TNBC and her2 positive breast cancer by comparing the efficacy of neoadjuvant with that of adjuvant treatment in improvement of RFS.
Read the detailed description
Neoadjuvant Chemotherapy (NCT) is a standard treatment of patients who hope breast-conserving therapy (BCT) with locally advanced inoperable breast cancer or large tumor size. it is beneficial to degrading the tumor stage, increasing the rate of surgical resection or the BCT.People who are pathological complete response (pCR) after NCT have an improvement in disease-free survival (DFS) and overall survival (OS), as well as better prognosis. Currently, breast cancer are entering into the era of molecular classification. Different molecular subtype of breast cancer showed a significant difference in prognosis; triple negative breast cancer (TNBC) and Her2 positive breast cancer are clinically relevant terms referring to a specific subtype of breast cancer with high malignant characteristics, early recurrence and metastasis, but sensitive to primary chemotherapy, proportion of which are 15% and 20% respectively. A meta analysis shows that TNBC and her2 positive breast cancer have a higher pCR than Luminal A/B, and the increasing in pCR rate means improvement in survival.
The investigators previous study indicates that paclitaxel plus carboplatin with or without trastuzumab can improve pCR and prolong RFS in TNBC and her2 positive breast cancer Comparing to adjuvant chemotherapy.
The investigators research aim to explores the optimal comprehensive treatment for TNBC and her2 positive breast cancer by comparing the efficacy of neoadjuvant with that of adjuvant treatment in improvement of RFS.
- Conditions
- Breast Cancer
- Being tested
- Neoadjuvant Chemotherapy, postoperative chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant ChemotherapyDrug
Also called preoperative chemotherapy
Neoadjuvant Chemotherapy: TNBC:paclitaxel (PTX) 175mg/m2 d1, Carboplatin area under the curve（AUC4） d2, q14d*6. HER-2 Positive BC: PTX 175mg/m2 d1, Carboplatin AUC4 d2, q14d*6, and plus Herceptin 2mg/kg qw, 6mg/kg q3w after chemotherapy until 1 year.
postoperative chemotherapyDrug
Also called Adjuvant Chemotherapy
postoperative chemotherapy: EC-P/D±H, paclitaxel and Carboplatin plus Herceptin(TCH）, EC/TC±H, and so on.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant chemotherapy | Experimental | Neoadjuvant Chemotherapy: TNBC:paclitaxel (PTX) 175mg/m2 d1, Carboplatin area under the curve（AUC4） d2, q14d*6. HER-2 Positive BC: PTX 175mg/m2 d1, Carboplatin AUC4 d2, q14d*6, and plus Herceptin 2mg/kg qw, 6mg/kg q3w after chemotherapy until 1 year. RECIST is used once every 2 cycles. Patients will finish 6 cycles preoperative chemotherapy when CR/partial response(PR)/stable disease(SD) by RECIST without serious adverse events. Receives: Drug: Neoadjuvant Chemotherapy |
| postoperative chemotherapy | Active comparator | Postoperative Chemotherapy:Standard chemotherapy regiments according to risk of recurrence: EC-P/D±H, paclitaxel and Carboplatin plus Herceptin(TCH）, EC/TC±H, and so on. Receives: Drug: postoperative chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-Free Survival (RFS) of neoadjuvant and adjuvant treatment in TNBC and her2 positive breast cancer
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study startOct 2014
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (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
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pin Zhang, Chinese Academy of Medical Sciences
- Investigators
- Pin Zhang, professor, Study director, Chinese Academy of Medical Sciences (CAMS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02934828
- Sponsor's protocol ID
- LC2014A04
- Status last verified
- Aug 2016
- First submitted
- 14 Aug 2016
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of Preoperative Chemotherapy or Postoperative Chemotherapy for Early Triple Negative or Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Operable Breast Cancer
- ClinicalTrials.gov ID
- NCT02934828
- Acronym / sponsor ID
- LC2014A04
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 17 Oct 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.
The investigators research aim to explores the optimal comprehensive treatment for TNBC and her2 positive breast cancer by comparing the efficacy of neoadjuvant with that of adjuvant treatment in improvement of RFS.
Detailed description
Neoadjuvant Chemotherapy (NCT) is a standard treatment of patients who hope breast-conserving therapy (BCT) with locally advanced inoperable breast cancer or large tumor size. it is beneficial to degrading the tumor stage, increasing the rate of surgical resection or the BCT.People who are pathological complete response (pCR) after NCT have an improvement in disease-free survival (DFS) and overall survival (OS), as well as better prognosis. Currently, breast cancer are entering into the era of molecular classification. Different molecular subtype of breast cancer showed a significant difference in prognosis; triple negative breast cancer (TNBC) and Her2 positive breast cancer are clinically relevant terms referring to a specific subtype of breast cancer with high malignant characteristics, early recurrence and metastasis, but sensitive to primary chemotherapy, proportion of which are 15% and 20% respectively. A meta analysis shows that TNBC and her2 positive breast cancer have a higher pCR than Luminal A/B, and the increasing in pCR rate means improvement in survival.
The investigators previous study indicates that paclitaxel plus carboplatin with or without trastuzumab can improve pCR and prolong RFS in TNBC and her2 positive breast cancer Comparing to adjuvant chemotherapy.
The investigators research aim to explores the optimal comprehensive treatment for TNBC and her2 positive breast cancer by comparing the efficacy of neoadjuvant with that of adjuvant treatment in improvement of RFS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant chemotherapy | Experimental | Drug: Neoadjuvant ChemotherapyNeoadjuvant Chemotherapy: TNBC:paclitaxel (PTX) 175mg/m2 d1, Carboplatin area under the curve（AUC4） d2, q14d*6. HER-2 Positive BC: PTX 175mg/m2 d1, Carboplatin AUC4 d2, q14d*6, and plus Herceptin 2mg/kg qw, 6mg/kg q3w after chemotherapy until 1 year. RECIST is used once every 2 cycles. Patients will finish 6 cycles preoperative chemotherapy when CR/partial response(PR)/stable disease(SD) by RECIST without serious adverse events. |
| postoperative chemotherapy | Active comparator | Drug: postoperative chemotherapyPostoperative Chemotherapy:Standard chemotherapy regiments according to risk of recurrence: EC-P/D±H, paclitaxel and Carboplatin plus Herceptin(TCH）, EC/TC±H, and so on. |
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)
- Invasive breast cancer confirmed by pathology evaluation of core biopsy
- Tumors must be ER/PgR status negative (immunohistochemistry（IHC） < 10%) and lack of HER2/neu overexpression or amplification as measured by local hospital pathology laboratory (IHC +/- fluorescence in situ hybridization (FISH) and IHC < 3+, and FISH < 2.2) as described in the NCCN Guidelines
- Female between18 to 70 years of age, Eastern Cooperative Oncology Group(ECOG) Performance Status 0 or 1
- Early-stage TNBC or HER2 positive breast cancer according to the American Joint Committee on Cancer (AJCC) Staging Manual Clinical Stage IIA or IIB, Stage IIIA operable breast cancer
- Previously untreated
Key exclusion criteria (5 listed)
- ICH:ER/PgR status positive
- HER2 positive breast cancer Patients with reduced ejection fraction <50% are not eligible
- Patients with second malignancies
- Patients with bilateral breast cancer
- allergic constitution
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 |
|---|---|---|
| Neoadjuvant ChemotherapyAlso: preoperative chemotherapyNeoadjuvant Chemotherapy: TNBC:paclitaxel (PTX) 175mg/m2 d1, Carboplatin area under the curve（AUC4） d2, q14d*6. HER-2 Positive BC: PTX 175mg/m2 d1, Carboplatin AUC4 d2, q14d*6, and plus Herceptin 2mg/kg qw, 6mg/kg q3w after chemotherapy until 1 year. | Drug | Neoadjuvant chemotherapy |
| postoperative chemotherapyAlso: Adjuvant Chemotherapypostoperative chemotherapy: EC-P/D±H, paclitaxel and Carboplatin plus Herceptin(TCH）, EC/TC±H, and so on. | Drug | postoperative chemotherapy |
Primary outcome
Recurrence-Free Survival (RFS) of neoadjuvant and adjuvant treatment in TNBC and her2 positive breast cancer
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
- Individual participant dataSharing planned: Undecided
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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.
Pin Zhang, professor study director
Chinese Academy of Medical Sciences (CAMS)
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 Neoadjuvant Chemotherapy and postoperative chemotherapy in people with 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 7 inclusion and 5 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 18 Oct 2016. 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 Pin Zhang, professor (13701275563, Zhang_pin@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-Free Survival (RFS) of neoadjuvant and adjuvant treatment in TNBC and her2 positive breast cancer (time frame: 5 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 18 Oct 2016.