Triple Negative Breast CancerPhase 4NCT02615457
Huaier Granule in Treating Women With Triple Negative Breast Cancer
A Phase 4 study testing Huaier Granule in people with Triple Negative Breast Cancer, run by Shandong University at 1 site in China.
Trial summary
RATIONALE: Huaier (Trametes robiniophila Murr) is a traditional Chinese medicine, which has been widely used in China for many years. The investigators previous study has reported that Huaier could exert great inhibitory effects on breast cancer cells both in vitro and in vivo. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Triple Negative Breast Cancer
- What is being tested?
- Huaier Granule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Oct 2015to Oct 2025
- Phase
- Phase 4
- 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 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: ≥ 18 and ≤ 75 years, female;
- Triple negative breast cancer has been surgically removed;
- The triple negative breast cancer has been confirmed by pathological examination and Immunohistochemistry (IHC);
- Not receiving any preoperative anticancer drugs;
- The liver and kidney function satisfies the following conditions within 3 days after surgery (excluding day 3): aspartate aminotransferase (AST), glutamic-oxalacetic transaminase (ALT) < 2 upper limit of normal (ULN), total bilirubin ≤ 1.5 ULN, serum creatinine < 1.5 ULN;
- Other laboratory tests meet the following requirements within 3 days after surgery (excluding day 3): Hb ≥ 90g/l, platelet count ≥ 100×109/L, absolute neutrophil count > 1.5×109/L;
- The expected survival time ≥ 6 months;
- The subjects volunteer to sign the informed consent.
Who cannot join
- Patients with stage IV breast cancer;
- Triple negative breast cancer was not surgically removed;
- Non-triple negative breast cancer patients confirmed by pathological examination and Immunohistochemistry (IHC);
- Pregnant or lactating women;
- Those with active bleeding due to various reasons;
- Those with HIV infection or AIDS-associated diseases;
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- Those with severe acute and chronic diseases;
- Those with severe diabetes;
- Those with serious infectious diseases;
- Those who can not take drugs by oral route;
- Drug abusers or those with psychological or mental diseases that may interfere with study compliance;
- Conditions that are considered not suitable for this study investigators
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qilu hospital of Shandong University
Ji'nan, Shandong, 250012
Qifeng Yang, Professor, +86 18560085168
About this study
RATIONALE:
Huaier (Trametes robiniophila Murr) is a traditional Chinese medicine, which has been widely used in China for many years. The investigators previous study has reported that Huaier could exert great inhibitory effects on breast cancer cells both in vitro and in vivo.
PURPOSE:
To evaluate the efficacy and safety of Huaier Granule in treating women who have triple negative breast cancer that has been surgically removed.
Read the detailed description
OBJECTIVES:
Compare the disease-free survival (DFS) and overall survival (OS) of patients with triple negative breast cancer who are randomized to adjuvant Huaier Granule group vs. those randomized to Blank-control group.
OUTLINE:
Patients are randomized to the following one of two treatment groups and are followed annually.
Arm I: Patients taking Huaier Granule for adjuvant treatment after the triple negative breast cancer has been surgically removed.
Arm II: Patients not taking Huaier Granule after the triple negative breast cancer has been surgically removed.
- Conditions
- Triple Negative Breast Cancer
- Being tested
- Huaier Granule
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Huaier GranuleDrug
Huaier Granule was given orally, 20 g tid for 5 years.
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients taking Huaier Granule for adjuvant treatment after the triple negative breast cancer has been surgically removed. The Huaier Granule (Qidong Gaitianli Medicines Co., Ltd.) should be given orally from the 3rd day after surgery up to 5 years after surgery or until study termination. Receives: Drug: Huaier Granule |
| Arm II | No intervention | Patients not taking Huaier Granule after the triple negative breast cancer has been surgically removed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival (DFS)
Time from randomization to recurrence, metastasis, appearance of a second primary tumor, or death from any cause, whichever occurs first, assessed up to 10 years.
Measured: Up to 10 years
Secondary outcomes (1)
Overall survival (OS)
Time from randomization to death from any cause, assessed up to 10 years.
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Triple Negative Breast CancerStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qifeng Yang, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02615457
- Sponsor's protocol ID
- HECT001
- Status last verified
- Nov 2015
- First submitted
- 17 Nov 2015
- Last updated
- 26 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Wang X, Qi W, Li Y, Zhang N, Dong L, Sun M, Cun J, Zhang Y, Lv S, Yang Q. Huaier Extract Induces Autophagic Cell Death by Inhibiting the mTOR/S6K Pathway in Breast Cancer Cells. PLoS One. 2015 Jul 2;10(7):e0131771. doi: 10.1371/journal.pone.0131771. eCollection 2015.
PubMed 26134510Song X, Li Y, Zhang H, Yang Q. The anticancer effect of Huaier (Review). Oncol Rep. 2015 Jul;34(1):12-21. doi: 10.3892/or.2015.3950. Epub 2015 May 5.
PubMed 25955759Kong X, Ding X, Yang Q. Identification of multi-target effects of Huaier aqueous extract via microarray profiling in triple-negative breast cancer cells. Int J Oncol. 2015 May;46(5):2047-56. doi: 10.3892/ijo.2015.2932. Epub 2015 Mar 17.
PubMed 25826742Wang X, Zhang N, Huo Q, Sun M, Dong L, Zhang Y, Xu G, Yang Q. Huaier aqueous extract inhibits stem-like characteristics of MCF7 breast cancer cells via inactivation of hedgehog pathway. Tumour Biol. 2014 Nov;35(11):10805-13. doi: 10.1007/s13277-014-2390-2. Epub 2014 Jul 31.
PubMed 25077927Wang X, Zhang N, Huo Q, Sun M, Lv S, Yang Q. Huaier aqueous extract suppresses human breast cancer cell proliferation through inhibition of estrogen receptor alpha signaling. Int J Oncol. 2013 Jul;43(1):321-8. doi: 10.3892/ijo.2013.1947. Epub 2013 May 20.
PubMed 23686317Wang X, Zhang N, Huo Q, Yang Q. Anti-angiogenic and antitumor activities of Huaier aqueous extract. Oncol Rep. 2012 Oct;28(4):1167-75. doi: 10.3892/or.2012.1961. Epub 2012 Aug 8.
PubMed 22895629Zhang N, Kong X, Yan S, Yuan C, Yang Q. Huaier aqueous extract inhibits proliferation of breast cancer cells by inducing apoptosis. Cancer Sci. 2010 Nov;101(11):2375-83. doi: 10.1111/j.1349-7006.2010.01680.x.
PubMed 20718753
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Huaier Granule in Treating Women With Triple Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT02615457
- Acronym / sponsor ID
- HECT001
- Conditions
- Triple Negative Breast Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2025 (estimated)
- First posted
- 26 Nov 2015 (estimated)
- 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.
RATIONALE:
Huaier (Trametes robiniophila Murr) is a traditional Chinese medicine, which has been widely used in China for many years. The investigators previous study has reported that Huaier could exert great inhibitory effects on breast cancer cells both in vitro and in vivo.
PURPOSE:
To evaluate the efficacy and safety of Huaier Granule in treating women who have triple negative breast cancer that has been surgically removed.
Detailed description
OBJECTIVES:
Compare the disease-free survival (DFS) and overall survival (OS) of patients with triple negative breast cancer who are randomized to adjuvant Huaier Granule group vs. those randomized to Blank-control group.
OUTLINE:
Patients are randomized to the following one of two treatment groups and are followed annually.
Arm I: Patients taking Huaier Granule for adjuvant treatment after the triple negative breast cancer has been surgically removed.
Arm II: Patients not taking Huaier Granule after the triple negative breast cancer has been surgically removed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: Huaier GranulePatients taking Huaier Granule for adjuvant treatment after the triple negative breast cancer has been surgically removed. The Huaier Granule (Qidong Gaitianli Medicines Co., Ltd.) should be given orally from the 3rd day after surgery up to 5 years after surgery or until study termination. |
| Arm II | No intervention | –Patients not taking Huaier Granule after the triple negative breast cancer has been surgically removed. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age: ≥ 18 and ≤ 75 years, female;
- Triple negative breast cancer has been surgically removed;
- The triple negative breast cancer has been confirmed by pathological examination and Immunohistochemistry (IHC);
- Not receiving any preoperative anticancer drugs;
- The liver and kidney function satisfies the following conditions within 3 days after surgery (excluding day 3): aspartate aminotransferase (AST), glutamic-oxalacetic transaminase (ALT) < 2 upper limit of normal (ULN), total bilirubin ≤ 1.5 ULN, serum creatinine < 1.5 ULN;
Key exclusion criteria (12 listed)
- Patients with stage IV breast cancer;
- Triple negative breast cancer was not surgically removed;
- Non-triple negative breast cancer patients confirmed by pathological examination and Immunohistochemistry (IHC);
- Pregnant or lactating women;
- Those with active bleeding due to various reasons;
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 |
|---|---|---|
| Huaier GranuleHuaier Granule was given orally, 20 g tid for 5 years. | Drug | Arm I |
Primary outcome
Disease free survival (DFS)
Time frame: Up to 10 years
Time from randomization to recurrence, metastasis, appearance of a second primary tumor, or death from any cause, whichever occurs first, assessed up to 10 years.
1 secondary outcome
Overall survival (OS)
Time frame: Up to 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2015.
- Background: PubMed 26134510Wang X, Qi W, Li Y, Zhang N, Dong L, Sun M, Cun J, Zhang Y, Lv S, Yang Q. Huaier Extract Induces Autophagic Cell Death by Inhibiting the mTOR/S6K Pathway in Breast Cancer Cells. PLoS One. 2015 Jul 2;10(7):e0131771. doi: 10.1371/journal.pone.0131771. eCollection 2015.
- Background: PubMed 25955759Song X, Li Y, Zhang H, Yang Q. The anticancer effect of Huaier (Review). Oncol Rep. 2015 Jul;34(1):12-21. doi: 10.3892/or.2015.3950. Epub 2015 May 5.
- Background: PubMed 25826742Kong X, Ding X, Yang Q. Identification of multi-target effects of Huaier aqueous extract via microarray profiling in triple-negative breast cancer cells. Int J Oncol. 2015 May;46(5):2047-56. doi: 10.3892/ijo.2015.2932. Epub 2015 Mar 17.
- Background: PubMed 25077927Wang X, Zhang N, Huo Q, Sun M, Dong L, Zhang Y, Xu G, Yang Q. Huaier aqueous extract inhibits stem-like characteristics of MCF7 breast cancer cells via inactivation of hedgehog pathway. Tumour Biol. 2014 Nov;35(11):10805-13. doi: 10.1007/s13277-014-2390-2. Epub 2014 Jul 31.
- Background: PubMed 23686317Wang X, Zhang N, Huo Q, Sun M, Lv S, Yang Q. Huaier aqueous extract suppresses human breast cancer cell proliferation through inhibition of estrogen receptor alpha signaling. Int J Oncol. 2013 Jul;43(1):321-8. doi: 10.3892/ijo.2013.1947. Epub 2013 May 20.
- Background: PubMed 22895629Wang X, Zhang N, Huo Q, Yang Q. Anti-angiogenic and antitumor activities of Huaier aqueous extract. Oncol Rep. 2012 Oct;28(4):1167-75. doi: 10.3892/or.2012.1961. Epub 2012 Aug 8.
- Background: PubMed 20718753Zhang N, Kong X, Yan S, Yuan C, Yang Q. Huaier aqueous extract inhibits proliferation of breast cancer cells by inducing apoptosis. Cancer Sci. 2010 Nov;101(11):2375-83. doi: 10.1111/j.1349-7006.2010.01680.x.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Huaier Granule in people with Triple Negative Breast Cancer, run by Shandong University at 1 site in China.
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 8 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 26 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qifeng Yang, Professor (+8618560085168, qifengy_sdu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (DFS) (time frame: Up to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02615457, which also lists 7 linked publications.
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 26 Nov 2015.