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A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE)Sponsor: Hoffmann-La Roche Company division:
Product: : Kadcyla , TRASTUZUMAB EMTANSINE
Area: early breast cancer
Protocol B027938
- Inclusion Criteria:
- Adult patient, >/= 18 years of age
- HER2-positive breast cancer
- Histologically confirmed invasive breast carcinoma
- Clinical stage T1-4/N0-3/M0 at presentation (patients with T1a/bN0 tumors will not be eligible)
- Completion of preoperative systemic treatment consisting of at least 6 cycles with a total duration of at least 16 weeks, including at least 9 weeks of trastuzumab and at least 9 weeks of taxane-based therapy
- Adequate excision: surgical removal of all clinically evident disease in the breast and lymph nodes as specified in protocol
- Pathological evidence of residual invasive carcinoma in the breast or axillary lymph nodes following completion of preoperative therapy
- An interval of no more than 12 weeks between the date of surgery and the date of randomization
- Known hormone-receptor status
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate hematologic, renal and liver function
- Left ventricular ejection fraction (LVEF) >/= 50% at screening and no decrease in LVEF by more than 15% absolute points from pre-chemotherapy
- Women of childbearing potential and men with partners of childbearing potential must be willing to use effective contraception as defined by protocol for the duration of study treatment and for at least 6 months after the last dose of study treatment
- Documentation of hepatitis B virus and hepatitis C virus serology is required
Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below: hugoraulcastro@hotmail.com, or phone number 23857572 de 11:00 to 18:00, Monday to Friday
ALEX Study: A Randomized, Phase III Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) Patients
Sponsor: Hoffmann-La Roche Company division:
Product: Alectinib
Area: Lung cancer
Protocol B028984
- Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC that is ALK-positive as assessed by the Ventana IHC test
- Age >/= 18 years old
- Life expectancy of at least 12 weeks
- ECOG PS of 0-2
- Patients had no prior systemic treatment for advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC
- Adequate renal, hematologic and liver function
- Patients must have recovered from effects of any major surgery or significant traumatic injury at least 28 days before the first dose of study treatment
- Measurable disease (by RECIST v1.1) prior to the administration of study treatment
- Prior brain or leptomeningeal metastases allowed if asymptomatic and diagnosed incidentally at study baseline. If patients have neurological symptoms or signs due to CNS metastasis, patients need to complete whole brain radiation or gamma knife irradiation treatment at least 14 days before enrollment and be clinically stable
- Use of highly effective contraception as defined by the study protocol
Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below: hugoraulcastro@hotmail.com or phone number 23857572 de 11:00 to 18:00, Monday to Friday
A Study of Kadcyla (Trastuzumab Emtansine) Plus Perjeta (Pertuzumab) Following Anthracyclines in Comparison With Herceptin (Trastuzumab) Plus Perjeta and a Taxane Following Anthracyclines as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer
Sponsor: Hoffmann-La Roche Company division:
Product: Kadcyla , TRASTUZUMAB EMTANSINE
Area: breast cancer
Protocol B028407
- Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status
- Non-metastatic histologically confirmed primary invasive breast carcinoma that was operable
- HER2-positive breast cancer
- Known hormone receptor status of the primary tumor
- Adequately excised: patients must have undergone either breast-conserving surgery or mastectomy/nipple- or skin-sparing mastectomy
- Pathological tumor-node-metastasis staging (Union for International Cancer Control-American Joint Committee on Cancer [UICC/AJCC] 7th edition): Eligible patients must have either:
- Node-positive disease (pN >/= 1), any tumor size except T0, and any hormonal receptor status, or Node-negative disease (pN0) with pathologic tumor size >2.0 cm by standard local assessment AND negative for ER and PR determined by a central pathology laboratory
- Patients with synchronous bilateral invasive disease are eligible only if both lesions are HER2 positive
- No more than 9 weeks (63 days) may elapse between definitive breast surgery (or the last surgery if additional resection required for breast cancer) and randomization
Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below: hugoraulcastro@hotmail.com or phone number 23857572 de 11:00 to 18:00, Monday to Friday
Study of MK-3475 (Pembrolizumab) Versus Platinum-based Chemotherapy for Participants With PD-L1-positive Advanced or Metastatic Non-small Cell Lung Cancer (MK-3475-042/KEYNOTE-042)
Sponsor: Merck Sharp & Dohme Corp
Product: Keytruda, Pembrolizumab
Area: lung cancer
Protocol: Keynote 042
- Inclusion criteria:
- Histologically- or cytologically-confirmed diagnosis of advanced or metastatic NSCLC
- PD-L1 positive tumor
- At least one radiographically measurable lesion
- Life expectancy of at least 3 months
- No prior systemic chemotherapy for the treatment of the subject's advanced or metastatic disease (adjuvant therapy is allowed as long as completed at least 6 months prior to diagnosis of metastatic disease)
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Adequate organ function
- No prior malignancy, with the exception of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or in situ cancer, or has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy
- Submission of formalin-fixed diagnostic tumor tissue (in the case of participants having received adjuvant systemic therapy, the tissue should be taken after completion of this therapy)
- Female participants of childbearing potential must have a negative urine or serum pregnancy test and must be willing to use two adequate barrier methods of contraception starting with the screening visit through 120 days after the last dose of pembrolizumab or 180 days after the last dose of chemotherapeutic agents used in the study
- Male participants with a female partner(s) of child-bearing potential must be willing to use two adequate barrier methods of contraception from screening through 120 days after the last dose of pembrolizumab or 180 days after the last dose of chemotherapeutic agents used in the study
Exclusion criteria:
Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below: hugoraulcastro@hotmail.com or phone number 23857572 de 11:00 to 18:00, Monday to Friday
A Study of Herceptin (Trastuzumab) in Patients With Metastatic or Advanced Gastric Cancer With Disease Progression
Sponsor: Hoffmann-La Roche Company division:
Product: Kadcyla , TRASTUZUMAB EMTANSINE
Area: gastric cancer
Protocol: BO27952
Inclusion Criteria:
- adult patients 18-75 years of age;
- metastatic or advanced gastric cancer;
- disease progression under or after 1 prior platinum-based or 5-fluoropyrimidine-based chemotherapy for metastatic disease;
- >=4 weeks from last platinum-based or fluoropyrimidine-based chemotherapy;
- >=1 measurable lesion;
- HER2 overexpression (IHC [2+] or [3+]).
- Exclusion Criteria:
- concurrent chemotherapy or immunotherapy;
- brain or meningeal metastases;
- clinically significant cardiac disease, advanced pulmonary disease or severe dyspnoea;
- co-existing malignancies or malignancies diagnosed within last 5 years, except basal cell cancer or cervical cancer in situ;
- women who are pregnant or breastfeeding.
Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below: hugoraulcastro@hotmail.com or phone number 23857572 de 11:00 to 18:00, Monday to Friday