Clinical trial NCT02627248: Neoadjuvant Chemotherapy With or Without Huaier Granule in Treating Women With Locally Advanced Breast Cancer That Can Be Removed By Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Breast Cancer
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2015-12-10
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: * Inclusion Criteria:

  * 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.
* Exclusion Criteria:

  * 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

Primary outcomes:
measure: Pathologic complete response (pCR)
timeFrame: one month after operation
Secondary outcomes:
measure: Clinical Complete Response (cCR)
timeFrame: one month after the neoadjuvant chemotherapy
measure: Disease-free survival (DFS)
timeFrame: up to 10 years
measure: Overall survival (OS)
timeFrame: up to 10 years
Other outcomes:
measure: Heterogeneity of the HR status in core biopsy and the surgical specimen
timeFrame: one month after operation
measure: Heterogeneity of the HER2 status in core biopsy and the surgical specimen
timeFrame: one month after operation
measure: Change in serum immunomodulating cytokines
timeFrame: up to 1 years
measure: The effects of Huaier Granule on adverse events of neoadjuvant chemotherapy
timeFrame: up to 6 months
measure: The effects of Huaier Granule on sleep quality of patients
timeFrame: up to 2 years
Locations:
city: Ji'nan
country: China
facility: Qilu hospital of Shandong University
state: Shandong
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.