A phase III, randomized, open-label study to compare pharmacokinetics, efficacy and safety of subcutaneous (SC) trastuzumab with intravenous (IV) trastuzumab administered in women with HER2 positive early breast cancer (EBC).
- Conditions
- -C50 Malignant neoplasm of breastMalignant neoplasm of breastC50
- Registration Number
- PER-079-09
- Lead Sponsor
- F. HOFFMANN-LA ROCHE LTD.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 27
• Patients must have signed and dated an informed consent form.
• Female sex.
• Age> 18 years.
• Non-metastatic invasive primary adenocarcinoma of the breast, which is in clinical stage I (TI, NO, MO) to INC (any T, N3, MO) including inflammatory and multicentric breast cancer. to. with tumor size> 1 cm. b. histologically confirmed. C. Centrally confirmed positive HER2 (IHC3 + or ISH +) in the invasive component of the primary tumor.
• At least one measurable lesion in the breast or lymph nodes, according to the RECIST vi .0 criteria, except for inflammatory carcinoma (T4d).
• ECOG functional status of 0-1.
• Baseline LVEF> 55% measured by echocardiography or MUGA tomography before the first dose of trastuzumab.
• History of any previous invasive breast carcinoma (ipsi and / or contralateral).
• Past or current history of malignant neoplasms, except for those treated curatively
• Metastatic disease.
• Any previous therapy with anthracyclines.
• Previous use of anti-HER2 treatment for any reason or other biological treatment or previous immunotherapy.
• Concurrent cancer treatment in another Research test, including immunotherapy.
• Patients with severe dyspnea at rest or who require complementary oxygen therapy, patients with other serious concurrent diseases that may interfere with the planned treatment including severe lung conditions / diseases.
• Serious heart disease or medical conditions that could prevent the use of trastuzumab, specifically: a history of documented CHF, uncontrolled high-risk arrhythmias, angina requiring medication, clinically significant valve disease, evidence of transmural infarction in ECG, poor hypertension controlled.
• Medical conditions that could prevent the use of 5-fluorouracil, epirubicin, cyclophosphamide or docetaxel, including: cystitis, urinary obstruction, active infections or severe mucositis.
• History of severe allergic and immunological reactions, p. eg, difficulty controlling asthma.
• Known hypersensitivity to any of the study drugs or to any of the excipients, known hypersensitivity to murine proteins.
• Known deficiency of dihydropyrimidine dehydrogenase (DPD).
• Pregnant or breastfeeding women.
• Women potentially fertile or less than one year after menopause (unless they are surgically sterile) who cannot or are not willing to use appropriate contraceptive measures during the study treatment.
• Patients who are not willing or unable to comply with the protocol procedures.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Pre-dose samples were obtained prior to surgery (Cycle 8). The observed Ctrough was recorded, averaged among all participants, and expressed in micrograms per milliliter (μg/mL).<br><br>Measure:Observed Serum Trough Concentration (Ctrough) of Trastuzumab Prior to Surgery<br>Timepoints:Pre-dose (0 hours) on Day 1 of Cycle 8 (cycle length of 21 days)<br>;<br>Outcome name:Participants were evaluated following eight cycles of treatment and after surgery to assess for pCR, defined as absence of neoplastic invasive cells in the breast according to pathologist examination. The percentage of participants with pCR was reported, and the 95% CI for one-sample binomial was constructed using the Pearson-Clopper method.<br><br>Measure:Percentage of Participants With Pathological Complete Response (pCR)<br>Timepoints:After surgery following eight cycles of Herceptin + chemotherapy (approximately 6 months from Baseline)<br>
- Secondary Outcome Measures
Name Time Method