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

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Huaier Granule
Epirubicin
Docetaxel
Cyclophosphamide
Sponsored by
Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

  • 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

Sites / Locations

  • Qilu hospital of Shandong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Docetaxel, Epirubicin and Cyclophosphamide (TEC)

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

Epirubicin and Docetaxel (ET)

Epirubicin and Docetaxel+Huaier (ET+HE)

Arm 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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
December 3, 2015
Last Updated
December 8, 2015
Sponsor
Shandong University
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1. Study Identification

Unique Protocol Identification Number
NCT02627248
Brief Title
Neoadjuvant Chemotherapy With or Without Huaier Granule in Treating Women With Locally Advanced Breast Cancer That Can Be Removed By Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Recruiting
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Docetaxel, Epirubicin and Cyclophosphamide (TEC)
Arm Type
Experimental
Arm 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.
Arm Title
Docetaxel, Epirubicin and Cyclophosphamide + Huaier (TEC+HE)
Arm Type
Experimental
Arm 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.
Arm Title
Epirubicin and Docetaxel (ET)
Arm Type
Experimental
Arm 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.
Arm Title
Epirubicin and Docetaxel+Huaier (ET+HE)
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Huaier Granule
Intervention Description
20g tid, orally
Intervention Type
Drug
Intervention Name(s)
Epirubicin
Intervention Description
70 mg/m² ivdrip, d1 for both TEC and ET regimes
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
75 mg/m² ivdrip, d2 for both TEC and ET regimes
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
600 mg/m² ivdrip, d2 for TEC regimes
Primary Outcome Measure Information:
Title
Pathologic complete response (pCR)
Description
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).
Time Frame
one month after operation
Secondary Outcome Measure Information:
Title
Clinical Complete Response (cCR)
Description
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.
Time Frame
one month after the neoadjuvant chemotherapy
Title
Disease-free survival (DFS)
Description
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.
Time Frame
up to 10 years
Title
Overall survival (OS)
Description
OS was defined as the date of definitive surgery until the date of death from any cause, assessed up to 10 years.
Time Frame
up to 10 years
Other Pre-specified Outcome Measures:
Title
Heterogeneity of the HR status in core biopsy and the surgical specimen
Description
Evaluation of the HR and HER2 status with immunohistochemical (IHC) staining.
Time Frame
one month after operation
Title
Heterogeneity of the HER2 status in core biopsy and the surgical specimen
Description
Evaluation of the HR and HER2 status with immunohistochemical (IHC) staining.
Time Frame
one month after operation
Title
Change in serum immunomodulating cytokines
Description
Assessment of the change in serum immunomodulating cytokines by Bio-Plex Pro Assays.
Time Frame
up to 1 years
Title
The effects of Huaier Granule on adverse events of neoadjuvant chemotherapy
Description
The adverse events were evaluated with Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Time Frame
up to 6 months
Title
The effects of Huaier Granule on sleep quality of patients
Description
The sleep quality was evaluated with self reported VAS scale (0-10).
Time Frame
up to 2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Qilu hospital of Shandong University
City
Ji'nan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qifeng Yang, Professor
Phone
+86 18560085168
First Name & Middle Initial & Last Name & Degree
Ning Zhang, Resident
Phone
+86 18560085950

12. IPD Sharing Statement

Citations:
PubMed Identifier
26134510
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.
Results Reference
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PubMed Identifier
25955759
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.
Results Reference
background
PubMed Identifier
25826742
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.
Results Reference
background
PubMed Identifier
25077927
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.
Results Reference
background
PubMed Identifier
23686317
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.
Results Reference
background
PubMed Identifier
22895629
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.
Results Reference
background
PubMed Identifier
20718753
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.
Results Reference
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Neoadjuvant Chemotherapy With or Without Huaier Granule in Treating Women With Locally Advanced Breast Cancer That Can Be Removed By Surgery

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