Minocycline Hydrochloride in Reducing Chemotherapy Induced Depression and Anxiety in Patients With Stage I-III Breast Cancer

PRIMARY OBJECTIVES:

I. To evaluate anxiety and depression in women with stages I-III breast cancer during the
first 8 weeks of doxorubicin-based adjuvant therapy randomized to receive either minocycline
(minocycline hydrochloride) or placebo.

II. To evaluate markers of neuro-inflammation as assessed by blood based inflammatory
cytokines and C11-choline positron emission tomography (PET) in women with stages I-III
breast cancer during the first 8 weeks of doxorubicin-based adjuvant therapy randomized to
receive either minocycline or placebo.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Beginning 1 week prior to chemotherapy, patients receive minocycline hydrochloride
orally (PO) twice daily (BID) for 9 weeks.

ARM II: Beginning 1 week prior to chemotherapy, patients receive placebo PO BID for 9 weeks.

After completion of study treatment, patients are followed up for 6 months.

Inclusion Criteria:

- Women diagnosed with breast cancer stages I-III initiating first line adjuvant or
neoadjuvant doxorubicin hydrochloride (DOX) chemotherapy

- Postmenopausal defined as amenorrhea > 12 months or follicle stimulating hormone (FSH)
and estradiol in institutional postmenopausal range

- Ability to understand English and read and write at the 8th grade level and give a
written informed consent document

- For additional cohort, women with breast cancer stages I-III who currently on or
within 18 months of completing first line adjuvant or neoadjuvant DOX chemotherapy or
other chemotherapy for breast cancer.

Exclusion Criteria:

- Rheumatoid arthritis and other types of autoimmune and inflammatory joint disease,
with the exception of osteoarthritis and fibromyalgia

- Concurrent other malignancy or metastatic malignancy of any kind

- Reported diagnosis of major depression or anxiety disorder prior to breast cancer (BC)
diagnosis

- Currently prescribed psychotropic medications including anti-depressants

- Known bleeding disorders

- History of diabetes mellitus, heart disease or stroke

- Current use of warfarin or other anticoagulants

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, hypertension, or psychiatric illness/social situation that would limit
compliance with study requirements

- Pregnant or nursing women

- Concurrent use of daily full dose aspirin (>= 325 mg/day), nonsteroidal
anti-inflammatory drugs (NSAIDs) or NSAID-containing products or steroids; one month
washout period is required prior to randomization

- Unable to give informed consent

- Tetracycline allergy

- Any contraindication to magnetic resonance imaging (MRI)/PET examination including but
not limited to ferromagnetic metal in the body, pacemaker, or severe claustrophobia;
(however, this portion is optional and if patient is otherwise eligible, can enroll in
study without participating in imaging study)