Neoadjuvant Chemotherapy With or Without Huaier Granule in Treating Women With Locally Advanced Breast Cancer That Can Be Removed By Surgery

Shandong University

Status and phase: Enrolling; Phase 4

Conditions: Breast Cancer

Treatments: Drug: Docetaxel; Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Huaier Granule

Study type: Interventional

Funder types: Other

Identifiers

NCT02627248

HECT002

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 4 patient groups

Docetaxel, Epirubicin and Cyclophosphamide (TEC)

Experimental group

Description:

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.

Treatment:

Drug: Cyclophosphamide

Drug: Docetaxel

Drug: Epirubicin

Docetaxel, Epirubicin and Cyclophosphamide + Huaier (TEC+HE)

Experimental group

Description:

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.

Treatment:

Drug: Huaier Granule

Drug: Cyclophosphamide

Drug: Docetaxel

Drug: Epirubicin

Epirubicin and Docetaxel (ET)

Experimental group

Description:

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.

Treatment:

Drug: Docetaxel

Drug: Epirubicin

Epirubicin and Docetaxel+Huaier (ET+HE)

Experimental group

Description:

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.

Treatment:

Drug: Huaier Granule

Drug: Docetaxel

Drug: Epirubicin