Patient case: 73-year-old female with Pancreatic ductal adenocarcinoma. Genetic variant: ERBB3. Other conditions: Whipple, FNA.

Clinical trial: Pertuzumab in Platinum-Resistant Low Human Epidermal Growth Factor Receptor 3 (HER3) Messenger Ribonucleic Acid (mRNA) Epithelial Ovarian Cancer (PENELOPE)

Summary: This two-part, multicenter study will evaluate the safety, tolerability and efficacy of pertuzumab in combination with standard chemotherapy in women with recurrent platinum-resistant epithelial ovarian cancer. In the non-randomized Part 1 safety run-in, participants will receive pertuzumab plus either topotecan or paclitaxel. In the randomized, double-blind Part 2 of the study, participants will receive either pertuzumab or placebo in combination with chemotherapy (topotecan, paclitaxel, or gemcitabine).


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed epithelial ovarian, primary peritoneal, and/or fallopian tube cancer that is platinum-resistant or refractory
  -  Low Human epidermal growth factor receptor (HER) 3 messenger ribonucleic acid (mRNA) expression
  -  At least one measurable and/or non-measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version (V) 1.1
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
  -  Left ventricular ejection fraction (LVEF) greater than or equal to (>/=) 50 percent (%)
  -  Negative serum pregnancy test in women of childbearing potential
  -  Women of childbearing potential must agree to use effective contraception as defined by protocol during and for at least 6 months post study treatment
  Exclusion Criteria:
  -  Non-epithelial tumors
  -  Ovarian tumors with low malignant potential (borderline tumors)
  -  History of other malignancy of prognostic relevance within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma, or tumors with a negligible risk for metastasis or death, such as adequately controlled basal-cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or carcinoma in situ of the breast
  -  Previous treatment with more than 2 chemotherapy regimens
  -  Any prior radiotherapy to the pelvis or abdomen
  -  History or evidence on physical/neurological examination of central nervous system disease unrelated to cancer (uncontrolled seizures), unless adequately treated with standard medical therapy
  -  Pre-existing peripheral neuropathy >/= common toxicity criteria (CTC) grade 2 (applicable for paclitaxel cohort only)
  -  Inadequate organ function
  -  Uncontrolled hypertension or clinically significant cardiovascular disease
  -  Current known infection with human immunodeficiency virus (HIV) or active infection with hepatitis B virus (HBV), or hepatitis C virus (HCV)
  -  Current chronic daily treatment with corticosteroids (>/= 10 mg per day of methylprednisolone or equivalent), excluding inhaled steroids
  -  History of receiving any investigational treatment within 28 days prior to first study drug administration
  -  For Part 2 of the trial: prior enrollment into Part 1 of the trial
  -  Concurrent participation in any therapeutic clinical trial

Relevance to patient case: not relevant