Minocycline Hydrochloride in Reducing Chemotherapy-Induced Peripheral Neuropathy and Acute Pain in Patients With Breast Cancer Undergoing Treatment With Paclitaxel

PRIMARY OBJECTIVES:

I. To estimate whether minocycline hydrochloride (minocycline) can alleviate
paclitaxel-induced peripheral neuropathy.

II. To estimate whether minocycline can alleviate paclitaxel acute pain syndrome (P-APS).

III. To examine the possible relative toxicities related to minocycline therapy in this study
situation.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive minocycline hydrochloride orally (PO) twice daily (BID) on days 1-7.
Treatment repeats every 7 days for up to 12 courses in the absence of disease progression or
unacceptable toxicity.

ARM II: Patients receive a placebo PO BID on days 1-7. Treatment repeats every 7 days for up
to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of the study, patients are followed up every month for 6 months.

Inclusion Criteria:

- Ability to complete questionnaires by themselves or with assistance

- Planned paclitaxel at a dose of 80 mg/m2 IV given, in the adjuvant breast cancer
(postoperative or neo-adjuvant) setting, every week for a planned course of 12 weeks
without any other concurrent cytotoxic chemotherapy (trastuzumab and/or other antibody
and/or small molecule treatment is allowed, except for PARP inhibitors)

- Life expectancy > 6 months

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Negative pregnancy test (serum or urine) done =< 7 days prior to registration, for
women of childbearing potential only (determined per clinician discretion)

Exclusion Criteria:

- Any of the following:

- Pregnant women

- Nursing women

- Men or women of childbearing potential who are unwilling to employ adequate
contraception

- Previous diagnosis of diabetic neuropathy or peripheral neuropathy from any cause

- History of allergic or other adverse reactions to minocycline

- Prior exposure to neurotoxic chemotherapy

- Diagnosis of fibromyalgia

- Current or planned use of methoxyflurane, oral contraceptives, isotretinoin,
penicillin, or ergot alkaloids

- History of allergic or other adverse reactions to tetracycline