Neoadjuvant Chemotherapy With or Without Huaier Granule in Treating Women With Locally Advanced Breast Cancer That Can Be Removed By Surgery
NCT ID: NCT02627248
Last Updated: 2015-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
200 participants
INTERVENTIONAL
2015-10-31
2025-10-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Docetaxel, Epirubicin and Cyclophosphamide (TEC)
Six 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.
Epirubicin
70 mg/m² ivdrip, d1 for both TEC and ET regimes
Docetaxel
75 mg/m² ivdrip, d2 for both TEC and ET regimes
Cyclophosphamide
600 mg/m² ivdrip, d2 for TEC regimes
Docetaxel, Epirubicin and Cyclophosphamide + Huaier (TEC+HE)
Six 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.
Huaier Granule
20g tid, orally
Epirubicin
70 mg/m² ivdrip, d1 for both TEC and ET regimes
Docetaxel
75 mg/m² ivdrip, d2 for both TEC and ET regimes
Cyclophosphamide
600 mg/m² ivdrip, d2 for TEC regimes
Epirubicin and Docetaxel (ET)
Six 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
70 mg/m² ivdrip, d1 for both TEC and ET regimes
Docetaxel
75 mg/m² ivdrip, d2 for both TEC and ET regimes
Epirubicin and Docetaxel+Huaier (ET+HE)
Six 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.
Huaier Granule
20g tid, orally
Epirubicin
70 mg/m² ivdrip, d1 for both TEC and ET regimes
Docetaxel
75 mg/m² ivdrip, d2 for both TEC and ET regimes
Interventions
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Huaier Granule
20g tid, orally
Epirubicin
70 mg/m² ivdrip, d1 for both TEC and ET regimes
Docetaxel
75 mg/m² ivdrip, d2 for both TEC and ET regimes
Cyclophosphamide
600 mg/m² ivdrip, d2 for TEC regimes
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Shandong University
OTHER
Responsible Party
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Qifeng Yang
Professor
Locations
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Qilu hospital of Shandong University
Ji'nan, Shandong, China
Countries
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Facility Contacts
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Qifeng Yang, Professor
Role: primary
Ning Zhang, Resident
Role: backup
References
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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.
Song 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.
Kong 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.
Wang 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.
Wang 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.
Wang 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.
Zhang 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.
Other Identifiers
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HECT002
Identifier Type: -
Identifier Source: org_study_id