Tobacco Dependence in Breast Cancer Patients Scheduled for Mastectomy/Reconstructive Surgery Trial of Varenicline (Chantix)

• examine baseline factors that are associated with treatment response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  so as to identify patients most in need of more intensive cessation interventions.
• tolerability of and adherence [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  Adherence to study medication will be assessed by summarizing the medication logs. Tolerability will be assessed by percent of patients who discontinue study medication due to side effects. Using CTCAE 4.0
• rates of surgical complications [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  among tobacco dependent breast cancer patients. We will primarily use descriptive statistics to summarize the rates of surgical complications among tobacco dependent breast cancer patients, as indicated by the prevalence of surgical complications (i.e., occurrence of infection, skin flap necrosis, reconstructive flap failure, seroma, and hematoma) documented in the patient's medical record.

• examine baseline factors that are associated with treatment response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  so as to identify patients most in need of more intensive cessation interventions.
• tolerability of and adherence [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  Adherence to study medication will be assessed by summarizing the medication logs. Tolerability will be assessed by percent of patients who discontinue study medication due to side effects. Using CTCAE 4.0
• rates of surgical complications [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  among tobacco dependent breast cancer patients. We will primarily use descriptive statistics to summarize the rates of surgical complications among tobacco dependent breast cancer patients, as indicated by the prevalence of surical complications (i.e., occurrence of infection, skin flap necrosis, reconstructive flap failure, seroma, and hematoma) documented in the patient's medical record.

Breast cancer patients who smoke, especially those scheduled for surgery, are at greater risk for treatment complications. They may have problems with wound healing and more infections. The purpose of this study is to see if the researchers can find ways to help patients who have breast cancer and are scheduled to have mastectomy and reconstructive surgery quit smoking. They will compare two ways to help people quit smoking. Some patients will receive varenicline, a prescription medicine also known as Chantix,®. Other patients will receive a placebo drug. A placebo is an inactive substance that contains no medicine. All patients will receive smoking cessation counseling provided by our tobacco treatment specialists. They hope that what the researchers learn from this study will help us improve our smoking cessation treatment program for breast cancer patients scheduled for surgery.

• Breast Cancer
• Tobacco Dependence

• Drug: placebo
  Pts will receive the standard 12-week dosing regimen consisting of 1 mg po of study drug twice daily for 11 weeks,along with smoking cessation counseling, for 11 weeks with an initial dose titration to full strength during the 1st week as follows: 0.5 mg po once daily for 3 days titrated to 0.5mg po twice daily for 4 days. 154 pills will be supplied for the 12 week tx. In order to compensate for any accidentally dropped or lost pills during the study duration, a total of 175 pills will be given to the patient. Along with smoking cessation counseling, for 11 weeks. Pts will receive their medication from the MSK Pharmacy & equivalent dosing & side effect education from our Tobacco Cessation Nurse Practitioner. Tx with the study drug will begin after the initial counseling session. The surgeons & tobacco cessation nurses will be blinded regarding pts' assignment to medication or placebo tx arm. Likewise, pts will not be informed as to which medication condition they have been assigned.
• Drug: varenicline
  Pts will receive the standard 12-week dosing regimen consisting of 1 mg po of study drug twice daily for 11 weeks,along with smoking cessation counseling, for 11 weeks with an initial dose titration to full strength during the 1st week as follows: 0.5 mg po once daily for 3 days titrated to 0.5mg po twice daily for 4 days. 154 pills will be supplied for the 12 week tx. In order to compensate for any accidentally dropped or lost pills during the study duration, a total of 175 pills will be given to the patient. Along with smoking cessation counseling, for 11 weeks. Pts will receive their medication from the MSK Pharmacy & equivalent dosing & side effect education from our Tobacco Cessation Nurse Practitioner. Tx with the study drug will begin after the initial counseling session. The surgeons & tobacco cessation nurses will be blinded regarding pts' assignment to medication or placebo tx arm. Likewise, pts will not be informed as to which medication condition they have been assigned.

• Experimental: placebo
  This is a randomized, double-blind, placebo-controlled trial comparing the effectiveness and tolerability of varenicline with placebo for smoking cessation in 100 tobacco dependent breast cancer patients scheduled for mastectomy and/or breast reconstruction surgery.
  Intervention: Drug: placebo
• Experimental: varenicline
  This is a randomized, double-blind, placebo-controlled trial comparing the effectiveness and tolerability of varenicline with placebo for smoking cessation in 100 tobacco dependent breast cancer patients scheduled for mastectomy and/or breast reconstruction surgery.
  Intervention: Drug: varenicline

Inclusion Criteria:

• MSK patients recently diagnosed with breast cancer as per EMR or clinicians judgment with treatment plan to include mastectomy and/or breast reconstruction;
• Self-reported average of 10 cigarettes daily during the previous year AND at least 1 pack of cigarettes smoked within the last 7 days.
• Breast surgery scheduled at MSKCC > 14 days from enrollment;
• Advised to quit smoking and willing to receive smoking cessation counseling and treatment;

Exclusion Criteria:

• Patients less than 18 years of age because the safety and efficacy of varenicline have not yet been tested in children;
• Evidence of any known or suspected medical contraindications for use of varenicline (e.g., recent (within past two months) cardiovascular instability (including myocardial infarction or unstable angina; uncontrolled hypertension, significant neurological sequelae of cerebrovascular disease, or severe congestive heart failure (New York Heart Association class III or IV), severe chronic obstructive pulmonary disease; uncontrolled gastrointestinal, hepatic, or endocrine disease; or severe renal impairment.
• Self-reported use of other tobacco products (pipe, cigar, smokeless tobacco) or marijuana in last 30 days;
• Self-reported evidence of significant psychiatric history (e.g., schizophrenia, unstable bipolar disorder, panic disorder, untreated major depression) sufficient, in the investigators' judgment, to preclude participation in the clinical trial;
• Self-reported evidence of recent substance abuse or heavy alcohol use (> 14 drinks weekly) in the last 6 months;
• Self-reported evidence of recent (in the past 30 days) or planned use of nicotine replacement therapy (NRT) or other FDA approved cessation pharmacotherapy (bupropion);
• Pre-menopausal women who are pregnant as per EMR
• Women who are breast-feeding as per self-report.