Neoadjuvant Chemotherapy With or Without Huaier Granule in Treating Women With Locally Advanced Breast Cancer That Can Be Removed By Surgery
1 other identifier
interventional
200
1 country
1
Brief Summary
RATIONALE: Huaier (Trametes robiniophila Murr) is a traditional Chinese medicine, which has been widely used in China for many years. The investigators have found that Huaier could exert synergistic effects with Epirubicin, Cyclophosphamide, and Paclitaxel on breast cancer cells. It is not yet known whether combination chemotherapy is more effective when given together with Huaier in the neoadjuvant setting . PURPOSE: To evaluate the effects of treatment with Huaier Granule in managing locally advanced breast cancers with synergistic action of the neoadjuvant chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 breast-cancer
Started Oct 2015
Longer than P75 for phase_4 breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 3, 2015
CompletedFirst Posted
Study publicly available on registry
December 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2025
CompletedDecember 10, 2015
December 1, 2015
10 years
December 3, 2015
December 8, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Pathologic complete response (pCR)
A pCR in the breast was defined as no pathologic evidence of invasive disease (residual ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) was allowed).
one month after operation
Secondary Outcomes (3)
Clinical Complete Response (cCR)
one month after the neoadjuvant chemotherapy
Disease-free survival (DFS)
up to 10 years
Overall survival (OS)
up to 10 years
Other Outcomes (5)
Heterogeneity of the HR status in core biopsy and the surgical specimen
one month after operation
Heterogeneity of the HER2 status in core biopsy and the surgical specimen
one month after operation
Change in serum immunomodulating cytokines
up to 1 years
- +2 more other outcomes
Study Arms (4)
Docetaxel, Epirubicin and Cyclophosphamide (TEC)
EXPERIMENTALSix cycles of docetaxel (75 mg/m²), epirubicin (70 mg/m²) and cyclophosphamide (600 mg/m²). Patients will be treated with chemotherapy every 3 weeks (+/- 2 days ) in total. Huaier Granule will be not be administrated.
Docetaxel, Epirubicin and Cyclophosphamide + Huaier (TEC+HE)
EXPERIMENTALSix cycles of docetaxel (75 mg/m²), epirubicin (70 mg/m²) and cyclophosphamide (600 mg/m²). Patients will be treated with chemotherapy every 3 weeks (+/- 2 days ) in total. Huaier Granule will be administrated from the first cycle of chemotherapy until time of definitive surgery.
Epirubicin and Docetaxel (ET)
EXPERIMENTALSix cycles of epirubicin (70 mg/m²) and docetaxel (75 mg/m²). Patients will be treated with chemotherapy every 3 weeks (+/- 2 days ) in total. Huaier Granule will be not be administrated.
Epirubicin and Docetaxel+Huaier (ET+HE)
EXPERIMENTALSix cycles of epirubicin (70 mg/m²) and docetaxel (75 mg/m²). Patients will be treated with chemotherapy every 3 weeks (+/- 2 days ) in total. Huaier Granule will be administrated from the first cycle of chemotherapy until time of definitive surgery.
Interventions
20g tid, orally
70 mg/m² ivdrip, d1 for both TEC and ET regimes
75 mg/m² ivdrip, d2 for both TEC and ET regimes
600 mg/m² ivdrip, d2 for TEC regimes
Eligibility Criteria
You may qualify if:
- Age: ≥ 18, female;
- Breast cancer (TNM II, III, IV) larger than 2cm in maximal diameter able to benefit from neoadjuvant chemotherapy;
- Ductal or lobular histological type of the breast tumor;
- The diagnosis and breast cancer has been confirmed by pathological examination;
- The liver and kidney function satisfies the following conditions within 3 days after surgery (excluding day 3): aspartate aminotransferase (AST), glutamic-oxalacetic transaminase (ALT) \< 2 upper limit of normal (ULN), total bilirubin ≤ 1.5 ULN, serum creatinine \< 1.5 ULN;
- Other laboratory tests meet the following requirements within 3 days after surgery (excluding day 3): Hb ≥ 90g/l, platelet count ≥ 100×109/L, absolute neutrophil count \> 1.5×109/L;
- The expected survival time ≥ 8 months;
- The subjects volunteer to sign the informed consent.
You may not qualify if:
- Breast cancers of rare histological type (other than ductal and lobular);
- Noninvasive cancer;
- Presence of organ, bone, or skin metastases;
- Pregnant or lactating women;
- Those with active bleeding due to various reasons;
- Those with HIV infection or AIDS-associated diseases;
- Those with severe acute and chronic diseases;
- Those with severe diabetes;
- Those with serious infectious diseases;
- Those who can not take drugs by oral route;
- Drug abusers or those with psychological or mental diseases that may interfere with study compliance;
- Conditions that are considered not suitable for this study investigators
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Qilu hospital of Shandong University
Ji'nan, Shandong, 250012, China
Related Publications (7)
Wang X, Qi W, Li Y, Zhang N, Dong L, Sun M, Cun J, Zhang Y, Lv S, Yang Q. Huaier Extract Induces Autophagic Cell Death by Inhibiting the mTOR/S6K Pathway in Breast Cancer Cells. PLoS One. 2015 Jul 2;10(7):e0131771. doi: 10.1371/journal.pone.0131771. eCollection 2015.
PMID: 26134510BACKGROUNDSong X, Li Y, Zhang H, Yang Q. The anticancer effect of Huaier (Review). Oncol Rep. 2015 Jul;34(1):12-21. doi: 10.3892/or.2015.3950. Epub 2015 May 5.
PMID: 25955759BACKGROUNDKong X, Ding X, Yang Q. Identification of multi-target effects of Huaier aqueous extract via microarray profiling in triple-negative breast cancer cells. Int J Oncol. 2015 May;46(5):2047-56. doi: 10.3892/ijo.2015.2932. Epub 2015 Mar 17.
PMID: 25826742BACKGROUNDWang X, Zhang N, Huo Q, Sun M, Dong L, Zhang Y, Xu G, Yang Q. Huaier aqueous extract inhibits stem-like characteristics of MCF7 breast cancer cells via inactivation of hedgehog pathway. Tumour Biol. 2014 Nov;35(11):10805-13. doi: 10.1007/s13277-014-2390-2. Epub 2014 Jul 31.
PMID: 25077927BACKGROUNDWang X, Zhang N, Huo Q, Sun M, Lv S, Yang Q. Huaier aqueous extract suppresses human breast cancer cell proliferation through inhibition of estrogen receptor alpha signaling. Int J Oncol. 2013 Jul;43(1):321-8. doi: 10.3892/ijo.2013.1947. Epub 2013 May 20.
PMID: 23686317BACKGROUNDWang X, Zhang N, Huo Q, Yang Q. Anti-angiogenic and antitumor activities of Huaier aqueous extract. Oncol Rep. 2012 Oct;28(4):1167-75. doi: 10.3892/or.2012.1961. Epub 2012 Aug 8.
PMID: 22895629BACKGROUNDZhang N, Kong X, Yan S, Yuan C, Yang Q. Huaier aqueous extract inhibits proliferation of breast cancer cells by inducing apoptosis. Cancer Sci. 2010 Nov;101(11):2375-83. doi: 10.1111/j.1349-7006.2010.01680.x.
PMID: 20718753BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 3, 2015
First Posted
December 10, 2015
Study Start
October 1, 2015
Primary Completion
October 1, 2025
Study Completion
October 1, 2025
Last Updated
December 10, 2015
Record last verified: 2015-12