Breast Cancer
Conditions
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.
Interventions
DRUGHuaier Granule
20g tid, orally
DRUGEpirubicin
70 mg/m² ivdrip, d1 for both TEC and ET regimes
DRUGDocetaxel
75 mg/m² ivdrip, d2 for both TEC and ET regimes
DRUGCyclophosphamide
600 mg/m² ivdrip, d2 for TEC regimes
Sponsors
Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathologic complete response (pCR) | one month after operation | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Complete Response (cCR) | one month after the neoadjuvant chemotherapy | 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. |
| Disease-free survival (DFS) | up to 10 years | 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. |
| Overall survival (OS) | up to 10 years | OS was defined as the date of definitive surgery until the date of death from any cause, assessed up to 10 years. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Heterogeneity of the HR status in core biopsy and the surgical specimen | one month after operation | Evaluation of the HR and HER2 status with immunohistochemical (IHC) staining. |
| The effects of Huaier Granule on sleep quality of patients | up to 2 years | The sleep quality was evaluated with self reported VAS scale (0-10). |
| Heterogeneity of the HER2 status in core biopsy and the surgical specimen | one month after operation | Evaluation of the HR and HER2 status with immunohistochemical (IHC) staining. |
| Change in serum immunomodulating cytokines | up to 1 years | Assessment of the change in serum immunomodulating cytokines by Bio-Plex Pro Assays. |
| The effects of Huaier Granule on adverse events of neoadjuvant chemotherapy | up to 6 months | The adverse events were evaluated with Common Terminology Criteria for Adverse Events (CTCAE) v4.0. |
Countries
China
Outcome results
None listed