Assessing the Efficacy and Safety of Anti-HER2 Therapy in Nigerian Women With HER2+ Breast Cancer Before and After Surgery

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Chicago

About this trial

Doctors leading this study would like to learn about providing cancer treatment/therapies to Nigerian women with breast cancer based on their human epidermal growth factor receptor 2 (HER2) status. This study will focus on the efficacy and safety of anti-HER2 cancer treatment before and after surgery.

Eligibility criteria

Qualifiers

Women ages of 18 to 70 years old

Biopsy-accessible breast tumor of significant size for core needle biopsy /ultrasound measurable (≥ 2cm)

Measurable breast tumour using ultrasonography (≥ 2cm)

Patients with histologically confirmed carcinoma of the female breast with positive HER2 status

Disqualifiers

Pregnant or lactating women. Women of childbearing potential not using a reliable and appropriate contraceptive method. Postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential. Patients will agree to continue the use of acceptable form of contraception for 7 months from the date of last drug administration (Herceptin).

Patients with distant metastasis

Serious, uncontrolled, concurrent infection(s).

Patients who have received more than 4 weeks of tamoxifen therapy for this malignancy. Patient who have received tamoxifen or raloxifene for purposes of chemoprevention (e.g. Breast Cancer Prevention Trial or for other past indications (including previous breast cancer) are eligible. Tamoxifen or raloxifene therapy will be discontinued at least one month before the patient is enrolled on this study.

Trial design

Treatments tested in this trial

  • Trastuzumab emtansine
  • Pertuzumab Injection
  • Docetaxel
  • Tamoxifen
  • Letrozole
  • Goserelin

Treatment groups

74 Participants
are divided into 3 treatment groups

Sponsors and collaborators