SurvivalPG2 BEAM-SNCT07601113
PG2 Breast Cancer Evaluation in Adjuvant Medicine-Survival Study
An observational study of Survival, run by Kun-Ming Rau at 5 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Survival
- What is being tested?
- Astragalus polysaccharides 500 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 5 sitesTaiwan
- Study dates
- 27 May 2026to 30 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Non
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Taiwan5 sites
Chang Gung Memorial Hospital, Kaohsiung Branch
Kaohsiung City
E-Da Cancer Hospital
Kaohsiung City
Chang Gung Memorial Hospital, Lovers Lake branch
Keelung
Chang Gung Memorial Hospital, Taipei Branch
Taipei
Chang Gung Memorial Hospital, Linkou Branch
Taoyuan City
About this study
Official title: 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.
- Conditions
- Survival
- Being tested
- Astragalus polysaccharides 500 mg, Placebo
- Keywords
- astragalus polysaccharides, breast cancer, adjuvant chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Astragalus polysaccharides 500 mgDrug
Also called PG2 Lyo. Injection 500 mg
Adjuvant chemotherapy in combination with PG2
PlaceboDrug
Adjuvant chemotherapy in combination with Placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Astragalus polysaccharides 500 mg Receives: Drug: Astragalus polysaccharides 500 mg | |
| Control | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from random assignment to Aug 27, 2025
Secondary outcomes (2)
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.
Measured: from random assignment to Aug 27, 2025
Overall Survival
Time from random assignment until death from any cause.
Measured: from random assignment to Aug 27, 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start27 May 2026
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurvivalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kun-Ming Rau
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kun-Ming Rau, E-DA Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07601113
- Sponsor's protocol ID
- PH-CP026-1
- Acronym
- PG2 BEAM-S
- Status last verified
- Jul 2026
- First submitted
- 15 May 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Survival Follow-up of Stage II/II Breast Cancer Patients Receiving PG2 Combination With Adjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT07601113
- Acronym / sponsor ID
- PG2 BEAM-S / PH-CP026-1
- Conditions
- Survival
- Keywords
- astragalus polysaccharides, breast cancer, adjuvant chemotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Kun-Ming RauUniversity, hospital or other
- Study start
- 27 May 2026 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | – | Drug: Astragalus polysaccharides 500 mgAstragalus polysaccharides 500 mg |
| Control | – | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Non
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Astragalus polysaccharides 500 mgAlso: PG2 Lyo. Injection 500 mgAdjuvant chemotherapy in combination with PG2 | Drug | Treatment |
| PlaceboAdjuvant chemotherapy in combination with Placebo | Drug | Control |
Primary outcome
Distant metastasis-free survival
Time frame: from random assignment to Aug 27, 2025
Time from random assignment to any first event of distant recurrence, death from any cause, or second (non-breast) invasive cancer.
2 secondary outcomes
Disease-free survival
Time frame: from random assignment to Aug 27, 2025
Overall Survival
Time frame: from random assignment to Aug 27, 2025
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Survival, run by Kun-Ming Rau at 5 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distant metastasis-free survival (time frame: from random assignment to Aug 27, 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.