Breast CancerPhase 3PANSYNCT04193059
Study Comparing EC-T Verses PCb in the Adjuvant Chemotherapy of Non-triple Negative Breast Cancer
A Phase 3 study testing Paclitaxel, Carboplatin and Epirubicin in people with Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
This study is a randomized, single center, phase III clinical trial comparing the efficacy and safety of four cycles of epirubicin combined with cyclophosphamide followed by four cycles of docetaxel (EC*4-T*4) verses 6 cycles of weekly paclitaxel combined with carboplatin (PCb*6) in the adjuvant chemotherapy of… 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?
- Paclitaxel, Carboplatin and Epirubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,560 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2019to Jul 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Female patients aged 18-70 years old;
- Histologically confirmed unilateral invasive breast cancer (regardless of pathological type)
- Operable breast cancer at first diagnosis, without any absolute surgical contraindication.
- No gross nor microscopic residual tumor after surgery.
- HER2-positive with ≥ 1 positive axillary lymph node; or estrogen receptor (ER) and/or progesterone receptor (PR)-positive and HER2-negative with ≥ 4 positive axillary lymph node. HER2-positive is defined as an immunohistochemistry (IHC) status of 3+, or a positive in situ hybridization (Fluorescence in situ hybridization (FISH), Chromogenic in situ hybridization (CISH)) test. ER-positive is defined as immunohistochemistry showing that ≥ 1% of tumor cells were ER positive. PR-positive is defined as immunohistochemistry showing that ≥ 1% of tumor cells were PR positive.
- Preoperative examination found no evidence of metastasis in clinical examination nor imaging examination.
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- No peripheral neuropathy.
- Karnofsky score > 70.
- Good postoperative recovery, at least 1 week has passed since most recent surgery.
- Has adequate bone marrow function: leukocyte count > 4x10ˆ9 / L, absolute neutrophil count > 2x10ˆ9 /L; platelet count > 100x10ˆ9 /L, hemoglobin > 9g/dL.
- Has adequate liver function: alanine aminotransferase (ALT) < 1.5×upper limit of normal (ULN), aspartate aminotransferase (AST) < 1.5×ULN, alkaline phosphatase (AKP) < 2.5×ULN, total bilirubin (TBIL) < 1.5×ULN.
- Has adequate kidney function: serum creatinine < 1.5×ULN.
- Contraception during treatment for women of childbearing age.
- Has adequate cardiac function: echocardiography showed left ventricular ejection fraction (LVEF) > 50%.
- Participants voluntarily joined the study, has signed informed consent before any trial related activities are conducted, has good compliance and has agreed to follow-up.
Who cannot join
- Has received previous chemotherapy for late stage disease.
- Has bilateral breast cancer or bilateral carcinoma in situ.
- Has metastatic (Stage 4) breast cancer.
- Has clinical T4 lesion (UICC1987) (with skin involvement, mass adhesion and fixation, and inflammatory breast cancer).
- Has received neoadjuvant therapy (include chemotherapy, targeted therapy, radiotherapy or endocrine therapy).
- Has previous history of additional malignancy(with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ), including contralateral breast cancer.
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- Is already participating in another clinical trial.
- Has severe systemic disease and/or uncontrolled infection.
- Has insufficient cardiac function: echocardiography showed LVEF< 50%.
- Has suffered from severe cardiovascular and cerebrovascular diseases disease within the 6 months previous of randomization (such as unstable angina, chronic heart failure, uncontrolled hypertension with blood pressure>150/90 mmHg, myocardial infarction, or cerebrovascular accident.
- Has known allergy to chemotherapy drugs used in this study.
- Is pregnant, is breast feeding, or is a woman of childbearing age who cannot practice effective contraceptives during treatment and until 8 weeks after the end of treatment.
- Has entered the study, but pre-treatment examination showed a positive pregnancy test.
- Has a history of mental disorders, cognitive impairment, inability to understand the study protocol and side effects, inability to complete the study protocol and follow-up workers (systematic evaluation is required before the patient is enrolled into the study), or is without independent civil capacity.
- The researchers judged patients to be unsuitable for the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Study Comparing the Efficacy and Safety of Epirubicin Combined With Cyclophosphamide Followed by Docetaxel (EC-T) Verses Paclitaxel Combined With Carboplatin (PCb) in the Adjuvant Chemotherapy of Non-triple Negative Breast Cancer
This study is a randomized, single center, phase III clinical trial comparing the efficacy and safety of four cycles of epirubicin combined with cyclophosphamide followed by four cycles of docetaxel (EC*4-T*4) verses 6 cycles of weekly paclitaxel combined with carboplatin (PCb*6) in the adjuvant chemotherapy of non-triple negative breast cancer patients. The study is divided in to 2 branches: PANSY-1 and PANSY-2. PANSY-1 is a study of hormone receptor (HR)-positive/human epidermal growth factor receptor-2 (HER2)-negative patients with ≥4 positive lymph node, while PANSY-2 is a study of HER2-positive patients with ≥1 positive lymph node.
Read the detailed description
PANSY-1 will be comparing the efficacy and safety of four cycles of epirubicin combined with cyclophosphamide followed by four cycles of docetaxel (EC-T) verses six cycles of paclitaxel combined with carboplatin (PCb).
PANSY-2 will be comparing the efficacy and safety of four cycles of epirubicin combined with cyclophosphamide followed by four cycles of docetaxel with trastuzumab (EC-TH) verses six cycles of paclitaxel combined with carboplatin and trastuzumab (PCbH); both followed by 1 year adjuvant trastuzumab.
After pertuzumab became legally available in China, participants of PANSY-2 may choose to receive trastuzumab and pertuzumab dual targeted therapy, thus comparing the efficacy and safety of four cycles of epirubicin combined with cyclophosphamide followed by four cycles of docetaxel with trastuzumab and pertuzumab (EC-THP) verses six cycles of paclitaxel combined with carboplatin, trastuzumab and pertuzumab (PCbHP); both followed by 1 year adjuvant trastuzumab and pertuzumab.
With the inclusion of pertuzumab in China's medical insurance in January 2020, study protocols were revised to include dual targeted therapy for HER2-positive participants.
- Conditions
- Breast Cancer
- Being tested
- Paclitaxel, Carboplatin, Epirubicin, Cyclophosphamide, Trastuzumab
- Keywords
- adjuvant chemotherapy, epirubicin, cyclophosphamide, docetaxel, paclitaxel, carboplatin, trastuzumab, non-triple negative breast cancer, pertuzumab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
paclitaxel 80 mg/m^2 ivgtt d1, d8, d15, 28 days per cycle, 6 cycles.
CarboplatinDrug
carboplatin AUC=2 ivgtt d1, d8, d15, 28 days per cycle, 6 cycles.
EpirubicinDrug
epirubicin 90 mg/m^2 ivgtt d1, 21 days per cycle, 4 cycles.
CyclophosphamideDrug
cyclophosphamide 600 mg/m^2 iv d1, 21 days per cycle, 4 cycles.
TrastuzumabDrug
trastuzumab 6 mg/kg (loading dose 8mg/kg) ivgtt d1, 21 days per cycle with chemotherapy; or trastuzumab 2 mg/kg (loading dose 4mg/kg, w1) ivgtt d1, d8, d15, d22, 28 days per cycle with chemotherapy. After chemotherapy, patient will continue to complete 1 year of adjuvant trastuzumab (6 mg/kg ivgtt every 3 weeks).
PertuzumabDrug
pertuzumab 420mg (loading dose 840mg) ivgtt d1, 21 days per cycle with chemotherapy. After chemotherapy, patient will continue to complete 1 year of adjuvant pertuzumab (420mg ivgtt every 3 weeks).
DocetaxelDrug
docetaxel 100 mg/m^2 ivgtt d1, 21 days per cycle, 4 cycles.
| Study group | Role | What they receive |
|---|---|---|
| PANSY-1: EC-T | Active comparator | 4 cycles of EC (epirubicin 90 mg/m^2 ivgtt d1+ cyclophosphamide 600 mg/m^2 iv d1, 21 days per cycle), followed by 4 cycles of T (docetaxel 100 mg/m^2 ivgtt d1, 21 days per cycle) Receives: Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Docetaxel |
| PANSY-1: PCb | Experimental | 6 cycles of weekly PCb (paclitaxel 80 mg/m^2 ivgtt d1, d8, d15+ carboplatin Area Under Curve (AUC)=2 ivgtt d1, d8, d15, 28 days per cycle) Receives: Drug: Paclitaxel; Drug: Carboplatin |
| PANSY-2: EC-TH(P) | Active comparator | 4 cycles of EC (epirubicin 90 mg/m^2 ivgtt d1+cyclophosphamide 600 mg/m^2 iv d1, 21 days per cycle), followed by 4 cycles of TH(P) (docetaxel 100 mg/m^2 ivgtt d1 + trastuzumab 6 mg/kg (loading dose 8mg/kg) ivgtt d1, 21 days per cycle, with pertuzumab 420mg (loading dose 840mg) ivgtt d1, 21 days per cycle for participants receiving dual-targeted therapy). After 8 cycles of chemotherapy, patient will continue to complete 1 year of adjuvant trastuzumab (6 mg/kg ivgtt every 3 weeks), with pertuzumab (420mg ivgtt every 3 weeks) for participants receiving dual-targeted therapy. Receives: Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Trastuzumab; Drug: Pertuzumab; Drug: Docetaxel |
| PANSY-2: PCbH(P) | Experimental | 6 cycles of weekly PCbH(P) (paclitaxel 80 mg/m^2 ivgtt d1, d8, d15 + carboplatin AUC=2 ivgtt d1, d8, d15 + trastuzumab 2 mg/kg (loading dose 4mg/kg, w1) ivgtt d1, d8, d15, d22, 28 days per cycle, with pertuzumab 420mg (loading dose 840mg) ivgtt d1, 21 days per cycle for participants receiving dual-targeted therapy). Participants may also choose to receive trastuzumab 6 mg/kg (loading dose 8mg/kg) ivgtt d1, 21 days per cycle with chemotherapy. After 6 cycles of chemotherapy, patient will continue to complete 1 year of adjuvant trastuzumab (6 mg/kg ivgtt every 3 weeks), with pertuzumab (420mg ivgtt every 3 weeks) for participants receiving dual-targeted therapy. Receives: Drug: Paclitaxel; Drug: Carboplatin; Drug: Trastuzumab; Drug: Pertuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease free survival
Measured: 5 years
Secondary outcomes (4)
Invasive Disease Free Survival
Measured: 5 years
Distant Disease Free Survival
Measured: 5 years
Overall Survival
Measured: 5 years
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v4.0
Graded according to Common Terminology Criteria for Adverse Events (CTC-AE) 4.0 according to CTC-AE 4.0
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 posted10 Dec 2019
- Study start20 Dec 2019
- Primary completionJul 2026 (estimated)
- Study completionJul 2027 (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.
- More trials run by Fudan 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- PANSY-1: Arm 1: EC-T: 4 cycles of EC (epirubicin + cyclophosphamide), followed by 4 cycles of T (docetaxel) . Arm 2: PCb: 6 cycles of weekly PCb (paclitaxel + carboplatin). PANSY-2: Arm 1: EC-TH(P): 4 cycles of EC (epirubicin + cyclophosphamide), followed by 4 cycles of TH TH(P) (docetaxel + trastuzumab, with pertuzumab for participants receiving dual-targeted therapy). After completing chemotherapy, patient will continue to complete 1 year of adjuvant trastuzumab, with pertuzumab for participants receiving dual-targeted therapy. Arm 2: PCbH(P): 6 cycles of weekly PCbH(P) (paclitaxel + carboplatin + trastuzumab, with pertuzumab for participants receiving dual-targeted therapy. After completing chemotherapy, patient will continue to complete 1 year of adjuvant trastuzumab, with pertuzumab for participants receiving dual-targeted therapy.
- Masking
- None (open label)
- Enrolment
- 1,560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhimin Shao, Fudan University
- Investigators
- ZhiMin Shao, MD, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04193059
- Sponsor's protocol ID
- 2018-68-1461
- Acronym
- PANSY
- Status last verified
- Oct 2025
- First submitted
- 8 Dec 2019
- Last updated
- 26 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Comparing the Efficacy and Safety of Epirubicin Combined With Cyclophosphamide Followed by Docetaxel (EC-T) Verses Paclitaxel Combined With Carboplatin (PCb) in the Adjuvant Chemotherapy of Non-triple Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT04193059
- Acronym / sponsor ID
- PANSY / 2018-68-1461
- Conditions
- Breast Cancer
- Keywords
- adjuvant chemotherapy, epirubicin, cyclophosphamide, docetaxel, paclitaxel, carboplatin, trastuzumab, non-triple negative breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,560 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 20 Dec 2019 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 10 Dec 2019 (actual)
- 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 a randomized, single center, phase III clinical trial comparing the efficacy and safety of four cycles of epirubicin combined with cyclophosphamide followed by four cycles of docetaxel (EC*4-T*4) verses 6 cycles of weekly paclitaxel combined with carboplatin (PCb*6) in the adjuvant chemotherapy of non-triple negative breast cancer patients. The study is divided in to 2 branches: PANSY-1 and PANSY-2. PANSY-1 is a study of hormone receptor (HR)-positive/human epidermal growth factor receptor-2 (HER2)-negative patients with ≥4 positive lymph node, while PANSY-2 is a study of HER2-positive patients with ≥1 positive lymph node.
Detailed description
PANSY-1 will be comparing the efficacy and safety of four cycles of epirubicin combined with cyclophosphamide followed by four cycles of docetaxel (EC-T) verses six cycles of paclitaxel combined with carboplatin (PCb).
PANSY-2 will be comparing the efficacy and safety of four cycles of epirubicin combined with cyclophosphamide followed by four cycles of docetaxel with trastuzumab (EC-TH) verses six cycles of paclitaxel combined with carboplatin and trastuzumab (PCbH); both followed by 1 year adjuvant trastuzumab.
After pertuzumab became legally available in China, participants of PANSY-2 may choose to receive trastuzumab and pertuzumab dual targeted therapy, thus comparing the efficacy and safety of four cycles of epirubicin combined with cyclophosphamide followed by four cycles of docetaxel with trastuzumab and pertuzumab (EC-THP) verses six cycles of paclitaxel combined with carboplatin, trastuzumab and pertuzumab (PCbHP); both followed by 1 year adjuvant trastuzumab and pertuzumab.
With the inclusion of pertuzumab in China's medical insurance in January 2020, study protocols were revised to include dual targeted therapy for HER2-positive participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- PANSY-1: Arm 1: EC-T: 4 cycles of EC (epirubicin + cyclophosphamide), followed by 4 cycles of T (docetaxel) . Arm 2: PCb: 6 cycles of weekly PCb (paclitaxel + carboplatin). PANSY-2: Arm 1: EC-TH(P): 4 cycles of EC (epirubicin + cyclophosphamide), followed by 4 cycles of TH TH(P) (docetaxel + trastuzumab, with pertuzumab for participants receiving dual-targeted therapy). After completing chemotherapy, patient will continue to complete 1 year of adjuvant trastuzumab, with pertuzumab for participants receiving dual-targeted therapy. Arm 2: PCbH(P): 6 cycles of weekly PCbH(P) (paclitaxel + carboplatin + trastuzumab, with pertuzumab for participants receiving dual-targeted therapy. After completing chemotherapy, patient will continue to complete 1 year of adjuvant trastuzumab, with pertuzumab for participants receiving dual-targeted therapy.
| Arm | Type | Receives |
|---|---|---|
| PANSY-1: EC-T | Active comparator | Drug: Epirubicin, Drug: Cyclophosphamide, Drug: Docetaxel4 cycles of EC (epirubicin 90 mg/m^2 ivgtt d1+ cyclophosphamide 600 mg/m^2 iv d1, 21 days per cycle), followed by 4 cycles of T (docetaxel 100 mg/m^2 ivgtt d1, 21 days per cycle) |
| PANSY-1: PCb | Experimental | Drug: Paclitaxel, Drug: Carboplatin6 cycles of weekly PCb (paclitaxel 80 mg/m^2 ivgtt d1, d8, d15+ carboplatin Area Under Curve (AUC)=2 ivgtt d1, d8, d15, 28 days per cycle) |
| PANSY-2: EC-TH(P) | Active comparator | Drug: Epirubicin, Drug: Cyclophosphamide, Drug: Trastuzumab, Drug: Pertuzumab, Drug: Docetaxel4 cycles of EC (epirubicin 90 mg/m^2 ivgtt d1+cyclophosphamide 600 mg/m^2 iv d1, 21 days per cycle), followed by 4 cycles of TH(P) (docetaxel 100 mg/m^2 ivgtt d1 + trastuzumab 6 mg/kg (loading dose 8mg/kg) ivgtt d1, 21 days per cycle, with pertuzumab 420mg (loading dose 840mg) ivgtt d1, 21 days per cycle for participants receiving dual-targeted therapy). After 8 cycles of chemotherapy, patient will continue to complete 1 year of adjuvant trastuzumab (6 mg/kg ivgtt every 3 weeks), with pertuzumab (420mg ivgtt every 3 weeks) for participants receiving dual-targeted therapy. |
| PANSY-2: PCbH(P) | Experimental | Drug: Paclitaxel, Drug: Carboplatin, Drug: Trastuzumab, Drug: Pertuzumab6 cycles of weekly PCbH(P) (paclitaxel 80 mg/m^2 ivgtt d1, d8, d15 + carboplatin AUC=2 ivgtt d1, d8, d15 + trastuzumab 2 mg/kg (loading dose 4mg/kg, w1) ivgtt d1, d8, d15, d22, 28 days per cycle, with pertuzumab 420mg (loading dose 840mg) ivgtt d1, 21 days per cycle for participants receiving dual-targeted therapy). Participants may also choose to receive trastuzumab 6 mg/kg (loading dose 8mg/kg) ivgtt d1, 21 days per cycle with chemotherapy. After 6 cycles of chemotherapy, patient will continue to complete 1 year of adjuvant trastuzumab (6 mg/kg ivgtt every 3 weeks), with pertuzumab (420mg ivgtt every 3 weeks) for participants receiving dual-targeted therapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Female patients aged 18-70 years old;
- Histologically confirmed unilateral invasive breast cancer (regardless of pathological type)
- Operable breast cancer at first diagnosis, without any absolute surgical contraindication.
- No gross nor microscopic residual tumor after surgery.
- HER2-positive with ≥ 1 positive axillary lymph node; or estrogen receptor (ER) and/or progesterone receptor (PR)-positive and HER2-negative with ≥ 4 positive axillary lymph node. HER2-positive is defined as an immunohistochemistry (IHC) status of 3+, or a positive in situ hybridization (Fluorescence in situ hybridization (FISH), Chromogenic in situ hybridization (CISH)) test. ER-positive is defined as immunohistochemistry showing that ≥ 1% of tumor cells were ER positive. PR-positive is defined as immunohistochemistry showing that ≥ 1% of tumor cells were PR positive.
Key exclusion criteria (15 listed)
- Has received previous chemotherapy for late stage disease.
- Has bilateral breast cancer or bilateral carcinoma in situ.
- Has metastatic (Stage 4) breast cancer.
- Has clinical T4 lesion (UICC1987) (with skin involvement, mass adhesion and fixation, and inflammatory breast cancer).
- Has received neoadjuvant therapy (include chemotherapy, targeted therapy, radiotherapy or endocrine therapy).
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 |
|---|---|---|
| Paclitaxelpaclitaxel 80 mg/m^2 ivgtt d1, d8, d15, 28 days per cycle, 6 cycles. | Drug | PANSY-1: PCb, PANSY-2: PCbH(P) |
| Carboplatincarboplatin AUC=2 ivgtt d1, d8, d15, 28 days per cycle, 6 cycles. | Drug | PANSY-1: PCb, PANSY-2: PCbH(P) |
| Epirubicinepirubicin 90 mg/m^2 ivgtt d1, 21 days per cycle, 4 cycles. | Drug | PANSY-1: EC-T, PANSY-2: EC-TH(P) |
| Cyclophosphamidecyclophosphamide 600 mg/m^2 iv d1, 21 days per cycle, 4 cycles. | Drug | PANSY-1: EC-T, PANSY-2: EC-TH(P) |
| Trastuzumabtrastuzumab 6 mg/kg (loading dose 8mg/kg) ivgtt d1, 21 days per cycle with chemotherapy; or trastuzumab 2 mg/kg (loading dose 4mg/kg, w1) ivgtt d1, d8, d15, d22, 28 days per cycle with chemotherapy. After chemotherapy, patient will continue to complete 1 year of adjuvant trastuzumab (6 mg/kg ivgtt every 3 weeks). | Drug | PANSY-2: EC-TH(P), PANSY-2: PCbH(P) |
| Pertuzumabpertuzumab 420mg (loading dose 840mg) ivgtt d1, 21 days per cycle with chemotherapy. After chemotherapy, patient will continue to complete 1 year of adjuvant pertuzumab (420mg ivgtt every 3 weeks). | Drug | PANSY-2: EC-TH(P), PANSY-2: PCbH(P) |
| Docetaxeldocetaxel 100 mg/m^2 ivgtt d1, 21 days per cycle, 4 cycles. | Drug | PANSY-1: EC-T, PANSY-2: EC-TH(P) |
Primary outcome
disease free survival
Time frame: 5 years
4 secondary outcomes
Invasive Disease Free Survival
Time frame: 5 years
Distant Disease Free Survival
Time frame: 5 years
Overall Survival
Time frame: 5 years
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v4.0
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
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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.
ZhiMin Shao, MD, PhD principal investigator
Fudan University
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, Carboplatin and Epirubicin in people with Breast Cancer, run by Fudan University 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 15 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 26 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease free survival (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 26 Nov 2025.