Invasive Ductal Breast CancerPhase 3NCT02879513
Trial of Adjuvant Chemotherapy in Breast Cancer Patients With Pathological Partial Response and Complete Response to Neoadjuvant Chemotherapy
A Phase 3 study testing Paclitaxel, Cisplatin and Epirubicin in people with Invasive Ductal Breast Cancer and Tubular Breast Cancer, run by RenJi Hospital at 1 site in China.
Trial summary
This trial will compare the administration of 2 cycles of paclitaxel and cisplatin (DP) versus 4 cycles of CEF as adjuvant chemotherapy for the patients with locally advanced breast cancer and who were pathological partial response to DP as neoadjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Invasive Ductal Breast Cancer, Tubular Breast Cancer, Mucinous Breast Cancer
- What is being tested?
- Paclitaxel, Cisplatin and Epirubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Dec 2022
- 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
- Women aged ≥18years and ≤70 years;
- Patients with locally advanced breast caner and had weekly paclitaxel and cisplatin as neoadjuvant chemotherapy.
- Patients with pathological partial response or pathological complete response to neoadjuvant chemotherapy according to the Response Evaluation Criteria in Solid Tumors (RECIST).
- Endocrine therapy and trastuzumab were allowed to use.
- ECOG 0-2;
- Adequate bone marrow function:WBC≥4.0×109/L, Absolute neutrophil count（ANC）≥1.5×109/L, Platelets（PLT）≥100×109/L, Hemoglobin（Hb）≥90g/L;aspartate aminotransferase(AST),Alanine aminotransferase (ALT)≤1.5 upper normal limit (UNL), creatinine≤1.5 UNL, bilirubin≤1.5UNL;
- No obvious main organs dysfunction.
Who cannot join
- Unwilling or unable to use an acceptable method of contraception in 8 weeks (including 8 weeks) after final dose of test drug;
- Patient is pregnant or breast feeding;
- Metastatic breast cancer;
- Any evidence of sense or motor nerve disorders;
- Patients with medical conditions taht indicate intolerant to neoadjuvant therapy, including uncontrolled cardiovascular disease, severe infection;
- Any concurrent malignancy other than breast cancer;
- Know severe hypersensitivity to any drugs in this study.
Trial locations and contacts
1 site in 1 country.
Jinsong Lu, MD contact
China1 site, 1 recruiting
- Recruiting
Shanghai Jiaotong University School of Medicine, Renji Hospital
Shanghai, Shanghai Municipality, 200127
Jinsong Lu, MD, lujjss@163.com
About this study
Official title: A Randomized Phase III Trial of Comparing Combination Administration of Paclitaxel and Cisplatin Versus CEF as Adjuvant Chemotherapy in Breast Cancer Patients With Pathological Partial Response and Complete Response to Neoadjuvant Chemotherapy
This trial will compare the administration of 2 cycles of paclitaxel and cisplatin (DP) versus 4 cycles of CEF as adjuvant chemotherapy for the patients with locally advanced breast cancer and who were pathological partial response to DP as neoadjuvant chemotherapy. Those who had pathological complete response to DP will be randomized to have 2 cycles of DP or have no further chemotherapy.
Read the detailed description
All the patients who had neoadjuvant chemotherapy and had pathological complete response (pCR) or partial response to DP will enrolled in this trial. Those who had pCR will randmized to have two cycles of DP as adjuvant chemotherapy or have no further chemotherapy. Those patients who had PR will be randomized to have two cycles of DP or four cycles of CEF. All the patients with hormonal receptor positive or Her2 overexpress tumors are allowed to accept endocrine therapy or anti-Her2 target therapy.
- Conditions
- Invasive Ductal Breast Cancer, Tubular Breast Cancer, Mucinous Breast Cancer, Inflammatory Breast Cancer
- Being tested
- Paclitaxel, Cisplatin, Epirubicin, Cyclophosphamide, 5-fluoruracil
- Medical subject headings
- Carcinoma, Ductal, Breast, Inflammatory Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
Also called Taxol
CisplatinDrug
EpirubicinDrug
CyclophosphamideDrug
5-fluoruracilDrug
Also called 5-FU
| Study group | Role | What they receive |
|---|---|---|
| Switch to CEF | Active comparator | Epirubicin 75 mg/m² IV push on day 1 every 3 weeks for 4 cycles. Cyclophosphamide 500 mg/m² IV push on day 1 every 3 weeks. 5-fluoruracil 500 mg/m² IV push on day 1 every 3 weeks. Receives: Drug: Epirubicin; Drug: Cyclophosphamide; Drug: 5-fluoruracil |
| Continue the neoadjuvant regimen | Experimental | Paclitaxel: 80 mg/m² i.v. given weekly on day 1 q day 8 for 16 weeks. Cisplatin: 25 mg/m² weekly on day 1 ,8,and 15 q day 28 for 4 cycles. Receives: Drug: Paclitaxel; Drug: Cisplatin |
| Pathological complete response group with chemotherapy | Experimental | Paclitaxel: 80 mg/m² i.v. given weekly on day 1 q day 8 for 16 weeks. Cisplatin: 25 mg/m² weekly on day 1 ,8,and 15 q day 28 for 4 cycles. Receives: Drug: Paclitaxel; Drug: Cisplatin |
| Pathological complete response group with no chemotherapy | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival (DFS)
Measured: Up to 5 years
Secondary outcomes (5)
overall survival (OS)
Measured: Up to 5 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 4 months during adjuvant therapy
regional recurrence free survival (RRFS)
Measured: 5 years
local recurrence free survival (LRFS)
Measured: 5 years
distant-disease- free survival (DDFS)
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 posted25 Aug 2016 (estimated)
- Study startJan 2014
- Primary completionJun 2020 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Ductal Breast CancerStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinsong Lu, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02879513
- Sponsor's protocol ID
- RenJiH-BC-003
- Status last verified
- Mar 2019
- First submitted
- 17 Jul 2016
- Last updated
- 23 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Trial of Comparing Combination Administration of Paclitaxel and Cisplatin Versus CEF as Adjuvant Chemotherapy in Breast Cancer Patients With Pathological Partial Response and Complete Response to Neoadjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT02879513
- Acronym / sponsor ID
- RenJiH-BC-003
- Conditions
- Invasive Ductal Breast Cancer, Tubular Breast Cancer, Mucinous Breast Cancer, Inflammatory Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 25 Aug 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 trial will compare the administration of 2 cycles of paclitaxel and cisplatin (DP) versus 4 cycles of CEF as adjuvant chemotherapy for the patients with locally advanced breast cancer and who were pathological partial response to DP as neoadjuvant chemotherapy. Those who had pathological complete response to DP will be randomized to have 2 cycles of DP or have no further chemotherapy.
Detailed description
All the patients who had neoadjuvant chemotherapy and had pathological complete response (pCR) or partial response to DP will enrolled in this trial. Those who had pCR will randmized to have two cycles of DP as adjuvant chemotherapy or have no further chemotherapy. Those patients who had PR will be randomized to have two cycles of DP or four cycles of CEF. All the patients with hormonal receptor positive or Her2 overexpress tumors are allowed to accept endocrine therapy or anti-Her2 target therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Switch to CEF | Active comparator | Drug: Epirubicin, Drug: Cyclophosphamide, Drug: 5-fluoruracilEpirubicin 75 mg/m² IV push on day 1 every 3 weeks for 4 cycles. Cyclophosphamide 500 mg/m² IV push on day 1 every 3 weeks. 5-fluoruracil 500 mg/m² IV push on day 1 every 3 weeks. |
| Continue the neoadjuvant regimen | Experimental | Drug: Paclitaxel, Drug: CisplatinPaclitaxel: 80 mg/m² i.v. given weekly on day 1 q day 8 for 16 weeks. Cisplatin: 25 mg/m² weekly on day 1 ,8,and 15 q day 28 for 4 cycles. |
| Pathological complete response group with chemotherapy | Experimental | Drug: Paclitaxel, Drug: CisplatinPaclitaxel: 80 mg/m² i.v. given weekly on day 1 q day 8 for 16 weeks. Cisplatin: 25 mg/m² weekly on day 1 ,8,and 15 q day 28 for 4 cycles. |
| Pathological complete response group with no chemotherapy | No intervention | – |
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)
- Women aged ≥18years and ≤70 years;
- Patients with locally advanced breast caner and had weekly paclitaxel and cisplatin as neoadjuvant chemotherapy.
- Patients with pathological partial response or pathological complete response to neoadjuvant chemotherapy according to the Response Evaluation Criteria in Solid Tumors (RECIST).
- Endocrine therapy and trastuzumab were allowed to use.
- ECOG 0-2;
Key exclusion criteria (7 listed)
- Unwilling or unable to use an acceptable method of contraception in 8 weeks (including 8 weeks) after final dose of test drug;
- Patient is pregnant or breast feeding;
- Metastatic breast cancer;
- Any evidence of sense or motor nerve disorders;
- Patients with medical conditions taht indicate intolerant to neoadjuvant therapy, including uncontrolled cardiovascular disease, severe infection;
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 |
|---|---|---|
| PaclitaxelAlso: Taxol | Drug | Continue the neoadjuvant regimen, Pathological complete response group with chemotherapy |
| Cisplatin | Drug | Continue the neoadjuvant regimen, Pathological complete response group with chemotherapy |
| Epirubicin | Drug | Switch to CEF |
| Cyclophosphamide | Drug | Switch to CEF |
| 5-fluoruracilAlso: 5-FU | Drug | Switch to CEF |
Primary outcome
Disease-free survival (DFS)
Time frame: Up to 5 years
5 secondary outcomes
overall survival (OS)
Time frame: Up to 5 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 4 months during adjuvant therapy
regional recurrence free survival (RRFS)
Time frame: 5 years
local recurrence free survival (LRFS)
Time frame: 5 years
distant-disease- free survival (DDFS)
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 23 Mar 2020.
Related trials for Invasive Ductal Breast Cancer
RecruitingObservational study
Negative/Low Hormone Receptor And/or HER2 POsitive Lobular Invasive Breast Carcinoma - A Real-World International Cohort Study
Lobular Breast Carcinoma
Not yet recruitingPhase 4
FES PET/MRI for Occult Disease in Lobular Breast Cancer
Lobular Breast Carcinoma
RecruitingPhase 1/2
[18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications
Colorectal Cancer, Epithelial Ovarian Cancer
Active, not recruitingPhase 3
Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer
Breast Ductal Carcinoma In Situ, Invasive Breast Carcinoma
Active, not recruitingObservational study
IORT Following Breast Conserving Surgery for Early Stage Breast Cancer Registry
Breast Cancer
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.
Jinsong Lu, MD contact
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 Paclitaxel, Cisplatin and Epirubicin in people with Invasive Ductal Breast Cancer and Tubular Breast Cancer, run by RenJi Hospital 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 7 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 23 Mar 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jinsong Lu, MD (lujjss@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (DFS) (time frame: Up to 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 23 Mar 2020.