PG2 Treatment Among Stage II/III Breast Cancer Patients Receiving Adjuvant Chemotherapy

June 2, 2025 updated by: PhytoHealth Corporation

PG2 Treatment for Reduction of Chemotherapy-Induced Toxicity and Encouraging Compliance With Chemotherapy Among Stage II/III Breast Cancer Patients Receiving Adjuvant Chemotherapy

Adjuvant chemotherapy usually is recommended after surgery for breast cancer patients who are at significant risk for disseminated disease. Chemotherapy has been demonstrated to reduce the risk of breast cancer recurrence. Anthracycline-based regimens, including doxorubin or epilubicin, are the breast cancer adjuvant chemotherapy standards of care. Fatigue has also been identified as the most problem for breast cancer patients under adjuvant chemotherapy. In the current study, it is aimed to show that PG2 (astragalus polysaccharides) treatment among stage II/III breast patients under adjuvant EC regimen in reduction of chemotherapy-induced toxicity and encouraging compliance with chemotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung City, Taiwan, 824
        • E-Da Cancer Hospital
      • Kaohsiung City, Taiwan, 833
        • Chang Gung Memorial Hospital, Kaohsiung Branch
      • Keelung, Taiwan, 204
        • Chang Gung Memorial Hospital, Lovers Lake branch
      • Taipei City, Taiwan, 105
        • Chang Gung Memorial Hospital, Taipei Branch
      • Taoyuan City, Taiwan, 333
        • Chang Gung Memorial Hospital, Linkou Branch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Women who are able to provide informed consent
  • Age 20 years and older
  • Diagnosis of stage II to III breast cancer
  • Patients who had undergone surgery for breast cancer treatment.
  • Planning to receive anthracycline -based adjuvant chemotherapy
  • Have adequate bone marrow, liver, and renal function
  • ECOG ≦1
  • Willing and able to complete quality of life questionnaires.

Exclusion Criteria:

  • Pregnancy or lactating women.
  • Baseline BFI score >3.
  • History of chronic fatigue syndrome, uncontrolled active infection, active cardiac disease, poor controlled hypertension or diabetes mellitus, any serious medical condition, psychiatric illness, and regular steroid therapy as determined by investigators.
  • History of previous breast cancer or other malignancy within the past 3 years with the exception of adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer.
  • Known severe allergy to Astragalus membranaceus or its mayor extracts (polysaccharides).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
Placebo
Drug: Placebo
500 ml saline, 3 days via i.v. infusion per chemotherapy cycle
Procedure: EC Chemotherapy
Epirubicin plus Cyclophosphamide every 21 days
Experimental: Treatment
Astragalus polysaccharides 500 mg
Procedure: EC Chemotherapy
Epirubicin plus Cyclophosphamide every 21 days
Drug: Astragalus polysaccharides 500 mg
PG2 (500 mg in 500 ml saline), 3 days via i.v. infusion per chemotherapy cycle
Other Names:
  • PG2 Lyo. Injection 500 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in chemotherapy-related fatigue by brief fatigue Inventory
Time Frame: through 4 chemotherapy cycles (each cycle is 21 days)
through 4 chemotherapy cycles (each cycle is 21 days)
Incidence of Grade 3/4 neutropenia
Time Frame: through 4 chemotherapy cycles (each cycle is 21 days)
through 4 chemotherapy cycles (each cycle is 21 days)

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of other Grade 3/4 Hematologic Toxicities
Time Frame: through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)
through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)
Chemotherapy Dose Reductions
Time Frame: through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)
through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)
Days of chemotherapy delay
Time Frame: through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)
through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)
Cumulative Doses of G-CSF consumption
Time Frame: through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)
through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)
Health-related Quality of Life by EORTC QLQ-C30 & Br23
Time Frame: through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)
through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)
ECOG
Time Frame: through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)
through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PhytoHealth Corporation

Investigators

  • Principal Investigator: Kun-Ming Rau, MD, E-Da Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Actual)

May 26, 2021

Study Completion (Actual)

August 27, 2021

Study Registration Dates

First Submitted

September 26, 2017

First Submitted That Met QC Criteria

October 18, 2017

First Posted (Actual)

October 19, 2017

Study Record Updates

Last Update Posted (Actual)

June 4, 2025

Last Update Submitted That Met QC Criteria

June 2, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PH-CP026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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