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NCT Number: NCT03314805

PG2 Breast Cancer Evaluation in Adjuvant Medicine Study

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.

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Key information

Conditions

Cancer-related Fatigue Acquired agranulocytosis Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Neutropenia, Malignant Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Chang Gung Memorial Hospital, Kaohsiung Branch, Kaohsiung City, Taiwan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Astragalus polysaccharides 500 mg

Drug

PG2 (500 mg in 500 ml saline), 3 days via i.v. infusion per chemotherapy cycle

Other names: PG2 Lyo. Injection 500 mg

Placebo

Drug

500 ml saline, 3 days via i.v. infusion per chemotherapy cycle

EC Chemotherapy

Procedure

Epirubicin plus Cyclophosphamide every 21 days

Primary outcomes

  1. Change in chemotherapy-related fatigue by brief fatigue Inventory

    Time frame: through 4 chemotherapy cycles (each cycle is 21 days)

  2. Incidence of Grade 3/4 neutropenia

    Time frame: through 4 chemotherapy cycles (each cycle is 21 days)

Secondary outcomes

  1. Incidence of other Grade 3/4 Hematologic Toxicities

    Time frame: through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)

  2. Chemotherapy Dose Reductions

    Time frame: through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)

  3. Days of chemotherapy delay

    Time frame: through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)

  4. Cumulative Doses of G-CSF consumption

    Time frame: through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)

  5. 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)

  6. ECOG

    Time frame: through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)

Sponsors and collaborators

Lead sponsor

PhytoHealth Corporation

Industry

Registry information

Official study title

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

Acronym: PG2 BEAM

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Oct 19, 2017
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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