Chemotherapy for Elderly Patients Diagnosed With Localized HER2 Positive Breast Cancer

Breast Cancer Clinical Trial

Official title:

Neoadjuvant or Adjuvant Chemotherapy Without Anthracyclines for Elderly Patients Diagnosed With HER2 Positive Breast Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02102438
• Other study ID #: NP 477
• Status: Withdrawn
• Phase: N/A
• First received: March 31, 2014
• Last updated: August 30, 2016
• Start date: April 2014
• Est. completion date: April 2018

Study information

• Verified date: August 2016
• Source: Instituto do Cancer do Estado de São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2018
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• HER-2 Positive Breast Cancer

Intervention

Drug:
• Trastuzumab
Trastuzumab (at a loading dose of 4mg/kg and a maintenance dose of 2mg/kg) will be given concomitantly with chemotherapy. After completion of four chemotherapy cycles, Trastuzumab will be given at a dose of 6mg/kg every 21 days, for a total 14 cycles.
• Weekly Paclitaxel
Weekly paclitaxel at 80mg/m2 at D1, D8 and D15 in a 28-day cycle, for a total of 4 treatment cycles.
• Carboplatin
Carboplatin at an Area Under the Curve (AUC) of 2 at D1, D8 and D15 in a 28-day cycle, for a total of 4 treatment cycles.

Locations

Country	Name	City	State
Brazil	ICESP	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Instituto do Cancer do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Free Survival (DFS)	Disease Free Survival was defined as the time from randomization until first relapse (local, regional, or distant), contralateral breast cancer, or death from any cause.	3 years	No
Secondary	survival (OS)	Secondary end points are overall survival (OS), defined from the time from randomization until death from any cause, and safety.	2 years	Yes