Clinical Trials

Inclusion Criteria:

- Documentation of disease: Histologic diagnosis of metastatic breast cancer in women or
men

- Prior treatment- No previous exposure to GM1

- Planned administration of paclitaxel, either given weekly, or weekly 3 weeks on/1 week
off, to patients with metastatic cancer at a dose of 80 mg/m^2

- No planned treatment with concurrent immunotherapy

- Score of 1 (none) and/or 2 (a little) on the six individual European Organization for
Research and Treatment of Cancer (EORTC) Quality of Life questionnaire (QLQ)-
chemotherapy-induced peripheral neuropathy (CIPN)20 questions that quantify numbness
(N), tingling (T), and pain in the fingers/hands and toes/feet (Items #31-36)

- No diagnosis of fibromyalgia

- No history of significant respiratory tract infection and/or infectious diarrhea
within 14 days before registration

- No history of stroke or cerebrovascular accident in the past 6 months prior to
registration

- No history of diagnosed neurologic or psychiatric disorders, including epilepsy or
dementia

- For women of childbearing potential, not pregnant and not nursing, because this study
involves an investigational agent whose genotoxic, mutagenic and teratogenic effects
on the developing fetus and newborn are unknown.

Therefore, for women of childbearing potential, a negative pregnancy test done =< 7 days
prior to registration is required. Of note, a female of childbearing potential is a
sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy;
or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has
had menses at any time in the preceding 12 consecutive months)

- Ability to complete questionnaires by themselves or with assistance

- In order to complete the mandatory patient-completed measures, participants must be
able to speak and/or read English and/or Spanish

- Persons with impaired decision making such that they cannot understand the benefits or
risks of trial participation, per the judgement of the consenting clinician, will not
be eligible

- Age >= 18 years

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2

- Absolute neutrophil count (ANC) >= 1,000/mm^3

- Platelet count >= 100,000/mm^3

- Creatinine =< 1.5 x upper limit of normal (ULN)

- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 2.5 x upper
limit of normal (ULN)

- Total bilirubin =< 1.5 x ULN

- No planned use of duloxetine

- No planned use of cryotherapy, compression therapy, or cryocompression therapy at
study entry

Exclusion Criteria:

- N/A

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 8/31/23. Questions regarding updates should be directed to the study team contact.