Know Cancer

forgot password

Phase II Multicentered Study of Exemestane and Lapatinib in Advanced Hormone-responsive Breast Cancer

Phase 2
Not Enrolling
Breast Cancer

Thank you

Trial Information

Phase II Multicentered Study of Exemestane and Lapatinib in Advanced Hormone-responsive Breast Cancer

The recommended dose of lapatinib will be determined in the first part of the study. In the
second part of the study, patients will receive the recommended dose of lapatinib and
exemestane daily, taken orally.

Inclusion Criteria:

- Histological diagnosis of breast cancer

- Indication for hormonal therapy (ER and/or PgR positive)

- Stage IV disease

- Female gender

- Postmenopausal status (patients treated with LHRH analogs are eligible for the Phase
II part of the study)

- At least one target or non-target lesion according to RECIST criteria

- ECOG Performance Status 0-2

- Adequate bone marrow (neutrophils > or = 1.500/mm³, platelets > or = 100.000/mm³ and
hemoglobin > or = 9 g/dl), hepatic (GOT, GPT < 2.5 e bilirubin <1.25 times the value
of upper normal limit) and renal (creatinine < 1.25 times the value of upper normal
limit) function

- Adequate cardiac function (FEVS > or = 50%)

- Able to take oral medications

- Life expectancy > 3 months

- Signed informed consent

Exclusion Criteria:

- Any previous hormone therapy for metastatic disease

- More than one line of chemotherapy for metastatic disease (first line chemotherapy is

- Symptomatic cerebral metastases

- Planned concomitant radiation therapy in the first month of therapy (for those
patients participating in the dose finding phase of the study)

- Previous therapy with exemestane, including as adjuvant therapy (previous therapy
with non-steroidal aromatase inhibitors is permitted)

- Previous or concurrent malignancy in past 5 years (excluding adequately treated basal
cel or spinocellular skin cancer and in situ carcinoma of the cervix)

- Treatment with experimental pharmacologic therapy within 4 weeks of enrollment in the

- Unable or unwilling to provide signed informed consent

- Any concurrent illness that would, in the Investigator's opinion, contraindicate the
use of the study drugs.

- Active infection

- Assumption of CYP3A4 inhibitors or inducers (ketoconazole, itraconazole,
fluconazole, macrolide antibiotics, antidepressives, calcium-antagonists, cimetidine,
carbamazepine, phenytoin, barbiturates, rifampicin e glucocorticoids)

- Pregnancy or lactation

- Unable to comply with follow-up

- Active hepatobiliary disease (with the exception of Gilbert's syndrome, asymptomatic
biliary calculi, hepatic metastases or stabile chronic hepatopathy)

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

recommended dose of lapatinib given in combination with standard dose of exemestane in patients with advanced hormone-responsive breast cancer

Outcome Time Frame:

one month after dose selection for each of 3 possible dose levels

Safety Issue:


Principal Investigator

Andrea de Matteis, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

NCI Naples, Division of Medical Oncology C


Italy: Ethics Committee

Study ID:




Start Date:

December 2009

Completion Date:

March 2012

Related Keywords:

  • Breast Cancer
  • advanced breast cancer
  • hormone-responsive
  • metastatic breast cancer
  • Breast Neoplasms