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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Docetaxel, Epirubicin and Cyclophosphamide (TEC) | Experimental | 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. |
|
| Docetaxel, Epirubicin and Cyclophosphamide + Huaier (TEC+HE) | Experimental | 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. |
|
| Epirubicin and Docetaxel (ET) | Experimental | 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 and Docetaxel+Huaier (ET+HE) | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Huaier Granule | Drug | 20g tid, orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Complete Response (cCR) | A cCR was defined as achieving either a Complete Response (CR) or a Partial Response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. | one month after the neoadjuvant chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Heterogeneity of the HR status in core biopsy and the surgical specimen | Evaluation of the HR and HER2 status with immunohistochemical (IHC) staining. | one month after operation |
| Heterogeneity of the HER2 status in core biopsy and the surgical specimen |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu hospital of Shandong University | Recruiting | Ji'nan | Shandong | 250012 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26134510 | Background | 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. | |
| 25955759 | Background | 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. |
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| Epirubicin | Drug | 70 mg/m² ivdrip, d1 for both TEC and ET regimes |
|
| Docetaxel | Drug | 75 mg/m² ivdrip, d2 for both TEC and ET regimes |
|
| Cyclophosphamide | Drug | 600 mg/m² ivdrip, d2 for TEC regimes |
|
| Disease-free survival (DFS) | DFS was defined as the date of definitive surgery until the date of recurrence, metastasis, appearance of a second primary tumor, or death from any cause, whichever occurs first, assessed up to 10 years. | up to 10 years |
| Overall survival (OS) | OS was defined as the date of definitive surgery until the date of death from any cause, assessed up to 10 years. | up to 10 years |
Evaluation of the HR and HER2 status with immunohistochemical (IHC) staining.
| one month after operation |
| Change in serum immunomodulating cytokines | Assessment of the change in serum immunomodulating cytokines by Bio-Plex Pro Assays. | up to 1 years |
| The effects of Huaier Granule on adverse events of neoadjuvant chemotherapy | The adverse events were evaluated with Common Terminology Criteria for Adverse Events (CTCAE) v4.0. | up to 6 months |
| The effects of Huaier Granule on sleep quality of patients | The sleep quality was evaluated with self reported VAS scale (0-10). | up to 2 years |
| 25826742 | Background | 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. |
| 25077927 | Background | 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. |
| 23686317 | Background | 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. |
| 22895629 | Background | 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. |
| 20718753 | Background | 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. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D015251 | Epirubicin |
| D000077143 | Docetaxel |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D004317 | Doxorubicin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
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