GM1 to prevent nerve damage from albumin-paclitaxel in breast cancer patients.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled phase III trial that enrolled 352 patients who were assigned 1:1 to receive GM1 or placebo alongside albumin-paclitaxel chemotherapy. The primary endpoint is the proportion of patients with a FACT/GOG-Ntx score change greater than 12 from baseline at the end of GM1 treatment (cycle 4, day 21). Key eligibility included women aged 18–75 with histologically confirmed breast cancer scheduled for adjuvant or neoadjuvant albumin-paclitaxel, ECOG 0–1, adequate organ function, and no preexisting peripheral neuropathy. Safety, neuropathy severity measures, and quality of life were also monitored as secondary outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Voluntarily sign the informed consent form;
* Age: 18 to 75 years old;
* Female patients with breast cancer confirmed byhistological and/or cytological diagnostic basis for breast cancer and are intended to receive adjuvant/neoadjuvant therapy with Albumin paclitaxel regimens;
* ECOG: 0-1
* Adequate organ function level
* Glycated hemoglobin (HbA1c) \< 7.0%;
* For women of childbearing potential: use effective contraceptive measures for contraception from the date of signing the informed consent form until 30 days after the last use of the investigatory drug.
* Patients can accurately record or express the occurrence and severity of peripheral neuropathy through questionnaires.

Exclusion Criteria:

* Grade ≥1 peripheral neuropathy (CTCAE grade ≥1) or any of the first 4 items of FACT/GOG-Ntx ≥1;
* There are risk factors for peripheral neuropathy (excluding peripheral neuropathy caused by chemotherapy).
* History of another malignant tumors (except breast cancer)
* Symptoms such as muscle pain in the limbs that interfere with the evaluate of peripheral neuropathy;
* Uncontrolled cardiovascular and cerebrovascular system diseases or hypertension
* Active infections that require systematic treatment, including bacteria, fungi or viruses, within one week before first study drug use; Or infectious diarrhea occurred within 4 weeks before the first study drug use;
* Hereditary abnormal glycolipid metabolism, HIV infection or known Acquired Immune Deficiency Syndrome (AIDS); Positive syphilis antibody, active hepatitis B, active hepatitis C

Where it's running

• The Fifth Medical Center of the Chinese People's Liberation Army General Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: ZeFei Jiang, Chief Physician
• Email: jzf_cscobc@csco.org.cn
• Phone: 010-66947175

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Assessing Functional Impairments in CIPN Patients

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.