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Phase II Trial of Lapatinib in Combination With Everolimus in Triple Negative Metastatic or Locally Advanced Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Neoplasms, Breast Cancer, Cancer of the Breast

Thank you

Trial Information

Phase II Trial of Lapatinib in Combination With Everolimus in Triple Negative Metastatic or Locally Advanced Breast Cancer

Inclusion Criteria:

- Histologically or cytologically confirmed ER(-), PR(-), HER2(-) locally advanced or
metastatic breast cancer

- Disease progression following prior first line cytotoxic chemotherapy in metastatic

- At least 1 lesion measurable by RECIST criteria

- Age >18 years old

- Female

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Left ventricular ejection fraction (LVEF) > 50%

- ANC>1500/mm3; platelets >100,000/mm3; hemoglobin > 9 g/dL; serum creatinine < 1.5X
ULN; total bilirubin < 1.5X ULN, AST and ALT < 2.5X ULN

- Patients must be recovered from both acute and late effects of any prior surgery,
radiotherapy or other antineoplastic therapy

- Patients or their legal representatives must be able to read, understand and provide
informed consent to participate in the trial.

- Patients of childbearing potential agree to use an effective form of contraception
during the study and for 90 days following the last dose of study medication (an
effective form of contraception is an oral contraceptive or a double barrier method)

Exclusion Criteria:

- Patients with current active hepatic or biliary disease (except for patients with
Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver
disease per investigator assessment)

- Patients with an active infection or with a fever > 101.3 Fahrenheit within 3 days of
the first scheduled day of protocol treatment

- Patients with active CNS metastases. Patients with stable CNS disease, who have
undergone radiotherapy at least 4 weeks prior to the planned first protocol treatment
and who have been on a stable dose of corticosteroids for 3 weeks are eligible for
the trial

- History of prior malignancy within the past 5 years except for curatively treated
basal cell carcinoma of the skin or cervical intra-epithelial neoplasia with two
consecutive normal pap smears 6 months apart

- Patients who received radiotherapy to more than 25% of their bone marrow; or patients
who received radiotherapy to target lesions within 4 weeks of entry

- Patients who are receiving concurrent investigational therapy

- Peripheral neuropathy >= Grade 2

- Patients who are pregnant or lactating

- Any other medical condition, including mental illness or substance abuse, deemed by
the Investigator to be likely to interfere with a patient's ability to sign informed
consent, cooperate and participate in the study, or interfere with the interpretation
of the results.

- History of allogeneic transplant

- Known HIV or Hepatitis B or C (active, previously treated or both)

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Response rate will measured using RECIST criteria. Tumor assessment for all lesions must be performed every eight weeks while on study by CT scan.

Outcome Time Frame:

Tumor assessment for all lesions must be performed by CT scan every 8 weeks while on study.

Safety Issue:


Principal Investigator

William I Read, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University Winship Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

December 2010

Completion Date:

January 2014

Related Keywords:

  • Breast Neoplasms
  • Breast Cancer
  • Cancer of the Breast
  • Metastatic breast cancer
  • Triple negative breast cancer
  • ER/PR/HER2-negative breast cancer
  • Breast Neoplasms
  • Neoplasms



Grady Memorial Hospital Atlanta, Georgia  30335
Emory University Winship Cancer Institute Atlanta, Georgia  30322
Emory Midtown (Crawford Long Hospital) Atlanta, Georgia  30308