A Study of Pertuzumab in Addition to Chemotherapy and Herceptin (Trastuzumab) as Adjuvant Therapy in Patients With HER2-Positive Primary Breast Cancer
- Conditions
- Patients with operable HER2-positive primary breast cancerMedDRA version: 14.1Level: LLTClassification code 10065430Term: HER-2 positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-022902-41-IT
- Lead Sponsor
- ROCHE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 3806
1. Age = 18 years. 2. Eastern Cooperative Oncology Group (ECOG) performance status = 1. 3. Non-metastatic operable primary invasive carcinoma of the breast that is: a) Histologically confirmed; b) Adequately excised: • Patients must have undergone either a total mastectomy or breast conserving surgery. • For patients who undergo conservative surgery, the margins of the resected specimen must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS) as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection,additional operative procedures may be performed to obtain clear margins. If tumor is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible.Patients with margins positive for lobular carcinoma in situ (LCIS) are eligible without additional resection. • For patients who undergo mastectomy, marginsmust be free of gross residual tumor. Patients with microscopic positive margins are eligible (see radiation therapy requirements). c) pTNM staging: Pathological classification of regional lymph nodes:micrometastases (tumor deposits > 0.2 mm) are considered pN1, but isolated tumor cells (ITC) are considered pN0. • For patients with node-positive disease (pN = 1),any pT except T0. • For patients with node-negative disease (pN0): o Tumor size must be > 1.0 cm OR o For tumor size between > 0.5 cm and = 1.0 cm, at least one of the following features must be present: histologic/nuclear grade 3 OR negative for ER and PgR OR age < 35 years. o Enrollment of patients with node negative tumors = 1.0 cm will be limited to < 10% of the total number of randomized patients. • For multifocal (the presence of two or more tumor foci within a single quadrant of the breast) or multicentric disease (the presence of two or more tumor foci within different quadrants of the same breast), the size of the largest invasive tumor is to be used to determine T stage. • Patients with synchronous bilateral invasive disease are eligible so long as both lesions are HER2-positive. 4. Known hormone receptor status (estrogen receptor [ER] and progesterone receptor [PgR]). 5. The interval between definitive surgery for breast cancer and randomization must be at least 3 weeks but no more than 7 weeks and the patient must be willing and able to start treatment within 1 week of randomization. 6. Baseline LVEF = 55% measured by echocardiography(preferred) or MUGA scan. 7. Women of childbearing potential and male participants with partners of childbearing potential must agree to use a highly-effective”, non-hormonal form of contraception or two effective” forms of non-hormonal contraception by the patient and/or partner. Contraception must continue for the duration of study treatment and for at least 6 months after the last dose of study treatment.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 3200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 600
1. History of any prior (ipsi- and/or contralateral) invasive breast carcinoma. 2. History of non-breast malignancies within the 5 years prior to study entry*, except for the following: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinomas of the skin (*malignancies occurring more than 5 years prior to study entry are permitted if curatively treated with surgery alone). 3. Any clinical” T4 tumor as defined by TNM, including inflammatory breast cancer. 4. Any node-negative tumor = 0.5 cm regardless of other risk factors. 5. Any previous systemic chemotherapy (eg, neo-adjuvant or adjuvant) for cancer OR radiation therapy for cancer: – Patient with a past history of DCIS and/or LCIS are not allowed to enter the study if they have received any form of systemic therapy for its treatment; OR radiation therapy to the ipsilateral breast where invasive cancer subsequently develops. – Patients who had their DCIS/LCIS treated with surgery only are allowed to enter the study. – High risk patients who have received chemoprevention drugs in the past are not allowed to enter the study. 6. Prior use of anti-HER2 therapy (eg, lapatinib, neratinib or other tyrosine kinase inhibitors [TKIs]) for any reason or other prior biologic or immunotherapy for cancer. 7. Concurrent anti-cancer treatment in another investigational trial, including hormone therapy, bisphosphonate therapy and immunotherapy. 8. Serious cardiac illness or medical conditions. 9. Pregnant, lactating or women of childbearing potential without a negative pregnancy test (serum), within 7 days prior to randomization, irrespective of the method of contraception used.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method