Clinical trial NCT02102438: Chemotherapy for Elderly Patients Diagnosed With Localized HER2 Positive Breast Cancer
Official title: Neoadjuvant or Adjuvant Chemotherapy Without Anthracyclines for Elderly Patients Diagnosed With HER2 Positive Breast Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Cancer
HER-2 Positive Breast Cancer
Keywords: Elderly patients
Localized HER2+ Breast Cancer
Omission of anthracyclines
Neoadjuvant chemotherapy
Adjuvant chemotherapy
Safety information
Lead sponsor: Instituto do Cancer do Estado de São Paulo
Sponsor class: OTHER
First posted: 2014-04-03
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: There is major concern regarding chemotherapy related toxicity in the group of women older than 65 years old diagnosed with human epidermal growth factor receptor 2 (HER2) positive breast cancer (BC). Nevertheless, these patients are at a particularly high risk of breast cancer recurrence and death. Of note, older patients may experience higher risk for Trastuzumabe related cardiotoxicity, especially when this agent is combined with an anthracycline.

Recent studies have shown extremely favourable outcomes in early HER2+ BC patients treated with a combination of paclitaxel and trastuzumab, omitting anthracyclines from treatment.

Investigators sought to investigate safety and outcome data on a cohort of elderly patients treated with weekly paclitaxel combined with carboplatin and trastuzumab.

Detailed description: Breast cancer is the most common female cancer and the second most common cause of cancer death in women. BC incidence is markedly increased with aging.

Amplification or overexpression of HER2 oncogene is present in approximately 18 to 20% of primary invasive BC. In the absence of HER2 target therapy combined with adjuvant or neoadjuvant chemotherapy, HER2 overexpression or amplification is associated with high rates of disease recurrence and death.

There is major concern regarding chemotherapy related toxicity in the group of women older than 65 years old diagnosed with HER2 positive breast cancer. Nevertheless, these patients are at a particularly high risk of breast cancer recurrence and death. Of note, older patients may experience higher risk for Trastuzumabe related cardiotoxicity, especially when this agent is combined with an anthracycline.

Recent studies have shown extremely favourable outcomes in early HER2+ BC patients treated with a combination of paclitaxel and trastuzumab, omitting anthracyclines from treatment.

Investigators sought to investigate safety and outcome data on a cohort of elderly patients treated with weekly paclitaxel combined with carboplatin and trastuzumab.

Eligibility criteria: Inclusion Criteria:

* Clinical or Pathological Stage I- IIIA breast adenocarcinoma.
* HER2 overexpression or amplification defined by immunohistochemistry staining of +3 or positive fluorescence in situ hybridization (FISH) test.
* Age ≥ 65 years old.
* WHO performance status less than 2; adequate hematologic (granulocyte count ≥ 2 X 109/L, platelet count ≥100 X109/L) and hepatic (transaminases ≤ 1.5 X the upper limit of normal (ULN), alkaline phosphatases ≤ 2.5 times ULN, and bilirubin ≤ ULN) tests; and normal cardiac function (baseline left ventricular ejection fraction at least ≥ 55%)

Exclusion Criteria:

* Radiologic imaging of metastatic disease.
* History of cardiac disease contraindicating anthracyclines, uncontrolled essential hypertension or diabetes, stroke or any other comorbidity that could potentially compromise chemotherapy treatment, such as chronic obstructive pulmonary disease.
* Any previous treatment with anti HER2 therapy.

Primary outcomes:
measure: Disease Free Survival (DFS)
timeFrame: 3 years
Secondary outcomes:
measure: survival (OS)
timeFrame: 2 years
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: ICESP
Study officials:
affiliation: Instituto do Cancer do Estado de São Paulo
name: Debora de Gagliato, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto do Cancer do Estado de São Paulo
name: Max Se Mano, MD phD
role: STUDY_CHAIR
References: