Breast or Gynecologic Cancer, Improving Sexual Desire (NRG-CC004)

For a patient to be eligible for participation in this study, all of the following criteria must apply.

Prior to Step 1 Registration

• Score of < 9 on the PHQ-4
• Patients must have a FSFI desire subscale baseline score less than 3.3
  • NOTE-Both the PHQ4 and FSFI must be completed by the patient and data entered in Oncology Patient Enrollment Network (OPEN) at Step 1 registration to determine eligibility
• Diagnosis of breast or gynecologic cancer (examples are DCIS, LCIS, invasive breast, ovarian, endometrial, vulvar, cervical and vaginal)
• Completed definitive therapy consisting of surgery, chemotherapy or radiation therapy at least 180 days ago (may continue on Herceptin or endocrine therapy)
• Post menopausal as defined by at least ONE of the following:
  • 12 months (365 days) without a period,
  • Bilateral oophorectomy,
  • For women 57 and under, if at least one ovary and woman has had hysterectomy, must have follicle stimulating hormone (FSH) (> 30 mIU/mL) and estradiol in menopausal range per institution's laboratory (< 10 for ultra sensitive assay: < 25-30 otherwise);
  • At least one ovary intact and 180 days without a period with FSH (> 30 mIU/mL) and estradiol in menopausal range per institution's laboratory (< 10 for ultra sensitive assay: < 25-30 otherwise); Note: Women 58 and older do not have to have hormonal tests.
• History, physical and performance status of 2 or less within 180 days prior to registration
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN)
• Total bilirubin =< 1.5 x ULN
• Glomerular filtration rate > 90ml/min
• For breast cancer patients only, endocrine therapies are allowed (such as aromatase inhibitors, but not current tamoxifen. Prior tamoxifen is permitted with a 30 day wash out period). 
• Vaginal estrogen is allowed, for all protocol disease sites, if dose equal to or less than that in estring (< 7.5 mcg) and it has been used for at least 30 days with no plans to stop or alter use during the course of the study
• Antidepressants for mood and hot flashes, including SSRI's will be allowed if patients have been on a stable dose for the last 60 days and the dose is not expected to change during the course of the study; only subthreshold or low dose antidepressants will be allowed (e.g. Effexor up to 75 mg or Lexapro 5-10 mg or Celexa 10- 20 mg)
• The patient must provide study-specific informed consent prior to study entry/screening
• Women who report that their motivation/desire for sexual intimacy has decreased since her cancer diagnosis
• Able to swallow whole capsules
• Proficient in English (due to number of questionnaires not validated in other languages)
• Completion of the FSFI and PHQ4; both questionnaires will be required and data entered at the time of step 1 registration

Prior to Step 2 Randomization

• Completion of the following baseline quality of life forms: PHQ4, FSFI, PROMIS sexual function and satisfaction, PROMIS fatigue short form 8a, Impact of Treatment Scale, patient reported outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) items, and revised dyadic adjustment scale; these quality of life forms will be required and data must be entered in RAVE at step 2 registration; if available at the time of step 1 registration, step 2 registration can take place immediately after step 1; women who do not currently have a partner do not have to complete the revised dyadic adjustment scale; enter "no partner" for this form

A patient will not be eligible for participation in this study if any of the following criteria apply.

• Untreated depression, major depressive disorder (MDD), suicidal ideations or anxiety disorders in the past 5 years per the medical chart based on Diagnostic and Statistical Manual (DSM) IV diagnoses
• Seizure disorders
• Current or history of anorexia or bulimia in the past 5 years
• Allergy to bupropion
• Use of drugs metabolized by CYP2D6
• Stage IV cancer
• History of Parkinson's disease, multiple sclerosis or fibromyalgia
• Extensive pelvic exenteration surgery, surgeries which include partial or total vaginectomy with or without reconstruction; radical vulvectomy with or without remove of clitoris
• Women who are currently undergoing or planning to undergo reconstruction surgery during the course of the study; women who have completed reconstruction surgery must be 30 days from surgery
• Oral or transdermal estrogen therapy is not allowed
• Males are not permitted to participate
• Patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs after chronic use
• Patients who discontinue monoamine oxidase (MAO)-inhibitor (I)'s within 14 days prior to starting the investigational drug
• Poorly controlled hypertension (systolic blood pressure [BP] >= 160 mmHg or diastolic BP >= 100 mmHg) on three or more readings in the past 12 months
• Patients with active bipolar disorder
• Patients with impaired decision making as determined by the treating physician
• Concurrent use of bupropion
• Concomitant invasive malignancy requiring treatment other than non-melanomatous skin cancer.
• Previous or concurrent use of flibanserin.

To learn more, visit ClinicalTrials.Gov

Study Type

Phase II

Principal Investigator(s)

Amanda Hathaway, MD

Sponsor(s)

NRG Oncology