PG2 Breast Cancer Evaluation in Adjuvant Medicine-Survival Study (PG2 BEAM-S)

Retrospective Survival Follow-up of Stage II/II Breast Cancer Patients Receiving PG2 Combination With Adjuvant Chemotherapy

Astragalus polysaccharides (APS), acting as an immunomodulator, is known to modulate the tumor microenvironment and inhibit tumor growth and progression, thereby suggesting potential as an adjuvant cancer therapy to improve treatment outcomes.

PG2 (APS Injection) has completed a clinical trial (Protocol name: PG2 Treatment for Reduction of Chemotherapy-Induced Toxicity and Encouraging Compliance with Chemotherapy among Stage II/III Breast Cancer Patients Receiving Adjuvant Chemotherapy , NCT03314805, hereinafter called the parent trial) aimed to show that PG2 treatment among stage II/III breast patients under adjuvant Epirubicin and cyclophosphamide (EC) regimen in reduction of chemotherapy-induced toxicities and encouraging compliance with chemotherapy. This study will further explore whether the addition of PG2 can delay cancer recurrence or metastasis, thereby conferring substantial survival benefits for early breast cancer patients with adjuvant chemotherapy by retrospectively collecting recurrence, metastasis, and survival information from patients enrolled in the parent trial.

Study Overview

• Status: Active, not recruiting
• Conditions: Survival
• Intervention / Treatment: Drug: Astragalus polysaccharides 500 mg; Drug: Placebo

• Study Type: Observational
• Enrollment (Actual): 66

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who were previously enrolled in the [PG2 Treatment for Reduction of Chemotherapy-Induced Toxicity and Encouraging Compliance with Chemotherapy Among Stage II/III Breast Cancer Patients Receiving Adjuvant Chemotherapy/NCT03314805] study.

Description

Inclusion Criteria:

• Patients who were previously enrolled in the [PG2 Treatment for Reduction of Chemotherapy-Induced Toxicity and Encouraging Compliance with Chemotherapy Among Stage II/III Breast Cancer Patients Receiving Adjuvant Chemotherapy/NCT03314805] study.

Exclusion Criteria:

• Non

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treatment; Astragalus polysaccharides 500 mg	Drug: Astragalus polysaccharides 500 mg; Adjuvant chemotherapy in combination with PG2; Other Names: PG2 Lyo. Injection 500 mg
Control; Placebo	Drug: Placebo; Adjuvant chemotherapy in combination with Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distant metastasis-free survival	Time from random assignment to any first event of distant recurrence, death from any cause, or second (non-breast) invasive cancer.	from random assignment to Aug 27, 2025

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free survival	Time from random assignment to any first event of invasive ipsilateral or contralateral breast recurrence, local or regional invasive recurrence, distant recurrence, second (non-breast) invasive cancer, or death from any cause.	from random assignment to Aug 27, 2025
Overall Survival	Time from random assignment until death from any cause.	from random assignment to Aug 27, 2025

Collaborators and Investigators

• Sponsor: Kun-Ming Rau

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: May 15, 2026
• First Submitted That Met QC Criteria: May 15, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: breast cancer; adjuvant chemotherapy; astragalus polysaccharides
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: PH-CP026-1

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