ALTTO(Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation) trial
- Conditions
- HER2/ErbB2 positive primary breast cancer
- Registration Number
- JPRN-jRCT2080220464
- Lead Sponsor
- ovartis Pharma K.K
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 8000
1. Age>=18 years
2. Eastern Cooperative Oncology Group (ECOG) performance status=<1;
3. Non-metastatic operable primary invasive adenocarcinoma of the breast fulfilling the following:
a. Histologically confirmed;
b. Adequately excised (exceptions: patients who have 'non-resectable' deep margin invasion are eligible provided they have had or will receive radiotherapy encompassing the region concerned; patients with histologically documented infiltration of the skin (pT4) are eligible provided they have undergone or will receive radiotherapy encompassing the tumour bed);
c. Axilla dissected; sentinel node sampling is allowed, provided that axillary dissection follows confirmation of a positive sentinel node; sentinel node sampling alone is NOT acceptable after neoadjuvant chemotherapy (in patients receiving neoadjuvant chemotherapy lymph node status will be considered unknown, regardless of the results of post-chemotherapy axillary dissection);
d. Axillary node positive patient OR node negative patient with a tumour greater than or equal to 1.0 cm in greatest diameter. For clarification, isolated tumour cells (ITC) are considered pN0 and micrometastases are considered pN1.
4. Known hormone receptor status (ER/PgR or ER alone);
5. For Designs 1 and 2: Patient must have received at least four cycles of an approved anthracycline-based (neo-) adjuvant chemotherapy regimen or listed as an exception in Table 5.
For Design 1: Randomisation must be performed no longer than 12 weeks from Day 1 of the last chemotherapy cycle after obtaining a post-chemotherapy LVEF >=50. Study treatment must start no more than 14 days after randomisation.
For Design 2: Randomisation must be performed no longer than 6 weeks from Day 1 of the last anthracycline-containing chemotherapy cycle after obtaining a post-anthracycline chemotherapy LVEF >=50. Study treatment must start no more than 14 days after randomisation and must be concurrent with taxanes.
For Design 2B: Randomisation must be performed no longer than 8 weeks from definitive surgery. Non-anthracycline platinum containing regimen (docetaxel and carboplatin) and study treatment must start concomitantly and no more than 14 days after randomisation.
1. History of any prior (ipsi- and/or contralateral) invasive breast carcinoma;
2. Past (less than 10 years) or current history of malignant neoplasms, except for curatively treated 1) basal and squamous cell carcinoma of the skin or 2) carcinoma in situ of the cervix.
NOTE: Patients with a prior malignancy diagnosed greater than 10 years in the past who have been curatively treated with surgery ONLY, WITHOUT radiation therapy or systemic therapy (chemotherapy or endocrine) are eligible for the study. Patients with any prior diagnosis of invasive breast cancer or melanoma, at any time, are excluded from this study.
3. Any clinically staged T4 tumour, including inflammatory breast cancer;
4. Bilateral tumours;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>To compare disease-free survival (DFS) in patients with HER2 overexpressing and/or amplified breast cancer randomised to trastuzumab for one year versus lapatinib for one year versus weekly trastuzumab (12 or 18 weeks, according to assigned design) followed by a six-week washout period followed by lapatinib (28 or 34 weeks, according to assigned design) versus trastuzumab in combination with lapatinib for one year.
- Secondary Outcome Measures
Name Time Method safety<br>To evaluate the safety and tolerability