Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Second Affiliated Hospital, School of Medicine, Zhejiang University | OTHER |
| First Affiliated Hospital of Zhejiang University | OTHER |
| Sir Run Run Shaw Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a multicentric, open-label,non-randomized concurrent control, 1:1 match,non-inferiority trial that assesses the efficacy and safety of neoadjuvant chemotherapy regimen DC-T and EC-T in breast cancer patients.
OBJECTIVES: Determine the efficacy and safety of neoadjuvant chemotherapy regimen DC-T and EC-T in suitable breast cancer patients.
Participants are randomized to 1 of 2 treatment arms.
Patients in arms I and II will undergo physical examination, MRI, estimating of side effects every 4 cycles referring to RECIST (Response Evaluation Criteria In Solid Tumor) guideline. To adjust for potential bias, patients in DC-T arm were matched 1:1 to patients in the EC-T arm based on Her-2 and ER status. After finishing 8 cycles of neoadjuvant chemotherapy, every patient will receive mastectomy or breast-conserving surgery and then assess the pCR rate of primary lesion and axillary lymph nodes. Adjuvant radiotherapy and endocrine therapy will be taken if necessary. Every patient will be followed-up for five years to monitor survival condition.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DC Follow T | Experimental | Participants receive pegylated liposomal doxorubicin plus cyclophosphamide followed by docetaxel before surgery. |
|
| EC Follow T | Active Comparator | Participants receive epirubicin plus cyclophosphamide followed by docetaxel before surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegylated liposomal doxorubicin | Drug | a new kind of doxorubicin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete response rate | The pathological complete response rate of primary lesion and axillary lymph nodes | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Side effects | Determine side effects of these drugs like cardiotoxicity ,hematological toxicity,gastrointestinal symptoms and so on. | 5 years |
| Overall survival | Determine the overall survival at 5 years. |
Not provided
Inclusion Criteria:
Women aged : 18~70 years.
WHO (ECOG) performance status 0-2.
Patients who have read and understand the informed consent form and have given written informed consent.
Diagnosed as invasive breast cancer by core biopsy
Diagnosed pre-surgically as (cTNM Staging)Stage II-III and suit for neoadjuvant chemotherapy.
Patients had previously not received chemotherapy,radiotherapy or biotherapy.
Normal organ function,meeting the requirement of laboratory testing below:
Patients with measurable lesion assessed by imaging using the RECIST (Response Evaluation Criteria In Solid Tumor) guideline,(long diameter of primary lesion ≥1cm or minor diameter of lymph node ≥1.5cm);
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huang Jian, Dr | Contact | 8657187315009 | drhuangjiang@zju.edu.cn | |
| Zhang Zhigang, Dr | Contact | 8657187315009 | zzg2011@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Huang Jian, Dr | Second Affiliated Hospital of Zhejiang University School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer institute | Recruiting | Hangzhou | Zhejiang | 310009 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14998846 | Background | O'Brien ME, Wigler N, Inbar M, Rosso R, Grischke E, Santoro A, Catane R, Kieback DG, Tomczak P, Ackland SP, Orlandi F, Mellars L, Alland L, Tendler C; CAELYX Breast Cancer Study Group. Reduced cardiotoxicity and comparable efficacy in a phase III trial of pegylated liposomal doxorubicin HCl (CAELYX/Doxil) versus conventional doxorubicin for first-line treatment of metastatic breast cancer. Ann Oncol. 2004 Mar;15(3):440-9. doi: 10.1093/annonc/mdh097. | |
| 24847380 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C506643 | liposomal doxorubicin |
| C041277 | 1-dodecylpyridoxal |
| D003520 | Cyclophosphamide |
| D015251 | Epirubicin |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
Not provided
Not provided
| Women's Hospital School Of Medicine Zhejiang University |
| OTHER |
| Zhejiang Cancer Hospital | OTHER |
| Zhejiang Provincial People's Hospital | OTHER |
| Zhejiang Provincial Hospital of TCM | OTHER |
| First People's Hospital of Hangzhou | OTHER |
| Hangzhou Hospital of Traditional Chinese Medicine | OTHER |
| First Affiliated Hospital of Wenzhou Medical University | OTHER |
| Ningbo No. 1 Hospital | OTHER |
| Jinhua Central Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
| Cyclophosphamide | Drug | traditional chemotherapy drug |
|
|
| Epirubicin | Drug | traditional chemotherapy drug used in breast cancer |
|
|
| Docetaxel | Drug | traditional chemotherapy drug used in breast cancer |
|
|
| 5 years |
| Background |
| Vici P, Pizzuti L, Gamucci T, Sergi D, Conti F, Zampa G, Del Medico P, De Vita R, Pozzi M, Botti C, Di Filippo S, Tomao F, Sperduti I, Di Lauro L. Non-pegylated liposomal Doxorubicin-cyclophosphamide in sequential regimens with taxanes as neoadjuvant chemotherapy in breast cancer patients. J Cancer. 2014 Apr 25;5(6):398-405. doi: 10.7150/jca.9132. eCollection 2014. |
| 25981896 | Background | Gil-Gil MJ, Bellet M, Morales S, Ojeda B, Manso L, Mesia C, Garcia-Martinez E, Martinez-Janez N, Mele M, Llombart A, Pernas S, Villagrasa P, Blasco C, Baselga J. Pegylated liposomal doxorubicin plus cyclophosphamide followed by paclitaxel as primary chemotherapy in elderly or cardiotoxicity-prone patients with high-risk breast cancer: results of the phase II CAPRICE study. Breast Cancer Res Treat. 2015 Jun;151(3):597-606. doi: 10.1007/s10549-015-3415-2. Epub 2015 May 16. |
| 26951122 | Background | Uriarte-Pinto M, Escolano-Pueyo A, Gimeno-Ballester V, Pascual-Martinez O, Abad-Sazatornil MR, Agustin-Ferrandez MJ. Trastuzumab, non-pegylated liposomal-encapsulated doxorubicin and paclitaxel in the neoadjuvant setting of HER-2 positive breast cancer. Int J Clin Pharm. 2016 Apr;38(2):446-53. doi: 10.1007/s11096-016-0278-5. Epub 2016 Mar 7. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D004317 | Doxorubicin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |