Can a traditional chinese herb normalize breast cancer markers?
NCT ID NCT05871437
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests whether Huaier granules, a traditional Chinese medicine, can help reduce elevated tumor markers (CEA, CA125, CA153) to normal levels in people with early-stage breast cancer. About 232 participants will take the granules daily for a year alongside standard care. The goal is to see if the treatment improves marker recovery rates and is safe.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Huaier granules (a traditional Chinese medicine extract)
- What this could lead to
- If successful, this could show that Huaier granules help normalize tumor markers in early breast cancer, potentially offering a complementary therapy to standard care.
- What could go wrong
- This is an early-phase trial with a modest size (232 people). It focuses on tumor marker levels, not long-term survival or recurrence, so benefits may not translate to better outcomes. Side effects are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 232 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2025
An estimate. Start dates often move.
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 18 ≤ age ≤ 75 years old, regardless of gender. * Postoperative pathological diagnosis of breast cancer. * Imaging or pathological examination without evidence of recurrence or metastasis. * If tumor markers are elevated, it is necessary to go to the corresponding department for medical treatment or issue a corresponding examination when necessary to exclude recurrence, metastasis or the second primary tumor of breast cancer. * One or more tumor markers in CEA/CA125/CA153 exceed the upper limit of normal values. * The liver and kidney functions meet the following conditions: AST and ALT\< 3 ULN, total bilirubin ≤ 2 ULN, and blood creatinine\<1.5 ULN; * Other laboratory tests meet the following requirements: Hb ≥ 9g/dl, platelet count ≥ 60 × 10\^9/L, absolute neutrophil count\>1.0 × 10\^9/L. * The patient's ECOG physical state score is 0 or 1. * The subjects participated in this study voluntarily and signed an informed consent form. Exclusion Criteria: * Diagnosed as any other malignant tumor within the 5 years prior to enrollment, except for malignant tumors with low risk of metastasis and death (5-year survival rate\>90%), such as fully treated basal cell or squamous cell skin cancer or cervical cancer in situ. * Imaging or pathological confirmation of recurrence and metastasis. * Serious infections (CTCAE\>Level 2) occurred within the first 4 weeks of enrollment, such as severe pneumonia, bacteremia, and infection complications that require hospitalization; Symptoms and signs of infection or the need for oral or intravenous antibiotic treatment within 2 weeks prior to enrollment, excluding the use of prophylactic antibiotics. * Suffering from severe acute and chronic diseases. * Suffering from severe diabetes whose blood sugar cannot be effectively controlled. * Patients who are unable to take oral medication, those who are allergic to the ingredients of Huaier granules, and pregnant or lactating women. * Drug abusers, or those who suffer from psychological or mental illnesses that may interfere with research compliance. * The researcher believes that it is not suitable to participate in this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
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