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CompletedNCT07601113PG2 BEAM-SUpdated Jul 6, 2026

PG2 Breast Cancer Evaluation in Adjuvant Medicine-Survival Study

An observational study in Survival, sponsored by Kun-Ming Rau. Completed at 5 sites in Taiwan. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-07-06.

Sponsored by Kun-Ming Rau · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
66
Ages
20 Years and older
Sex
Female
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Study summary

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.

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Conditions studied

  • Survival

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Keywords

  • astragalus polysaccharides
  • breast cancer
  • adjuvant chemotherapy
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 66 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

This is the only study on the registry with Kun-Ming Rau as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years and older
Sexes eligible
Female
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.

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

Exclusion Criteria:

  • Non
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
66 participants (actual)
Patient registry
No

Groups and cohorts

  • Treatment

    Astragalus polysaccharides 500 mg

    Drug: Astragalus polysaccharides 500 mg

  • Control

    Placebo

    Drug: Placebo

Interventions

  • DrugAstragalus polysaccharides 500 mg

    Adjuvant chemotherapy in combination with PG2

    Also known as: PG2 Lyo. Injection 500 mg

  • DrugPlacebo

    Adjuvant chemotherapy in combination with Placebo

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: from random assignment to Aug 27, 2025

Secondary outcomes

  1. 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.

    Time frame: from random assignment to Aug 27, 2025

  2. Overall Survival

    Time from random assignment until death from any cause.

    Time frame: from random assignment to Aug 27, 2025

07

Study locations

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

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07601113
Lead sponsor
Kun-Ming Rau
Responsible party
Kun-Ming Rau (Vice Superintendent, E-DA Hospital) — Sponsor-investigator
First posted
May 22, 2026
Start date
May 27, 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026
Last update
Jul 6, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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