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Also known as Capecitabine monotherapy
Capecitabine · 6 trials · 7 indications
safety of a dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (riobciclib) plus endocrine therapy as compared to a dual HER2-targeted therapy with Herceptin® (trastuzumab) and Perjeta® (pertuzumab) plus chemotherapy (followed by endocrine therapy plus ribociclib in combination with trastuzumab and pertuzumab as maintenance therapy) by the proportion of patients experiencing any adverse event (as defined by the modified adverse event score)
CNS relapse is defined as the appearance of \>=1 enhancing lesion measuring \>=6 millimeters (mm) on T1Weighted (T1W) Magnetic Resonance Imaging (MRI) without CNS symptoms that were considered to be unequivocal based on all relevant radiological features (e.g., associated T2W signal abnormality); the appearance of any enhancing lesion on T1W MRI with CNS symptoms; unequivocal finding of leptomeningeal disease (defined as the dissemination of cancer throughout the spinal fluid), with or without symptoms; and unequivocal finding of multifocal intraparenchymal lesions with or without symptoms. In the event of the appearance of a \<6 mm lesions(s) without CNS lesions, or equivocal findings potentially suggesting leptomeningeal disease, these findings were followed with a subsequent scan within 6 weeks. If unequivocal progression was determined with the subsequent scan and/or CNS symptoms occurred, then CNS relapse crieria were met.
Progression-free survival was defined as the time from the date of randomization to the date of the first documented progression as per local review and according to RECIST 1.1 or death due to any cause. PFS was censored at the date of the last adequate tumor assessment if no PFS event was observed at the time of last patient, last visit (LPLV).
Progression Free Survival (PFS) is defined as the time from date of randomization to the date of first radiologically documented progression or death due to any cause. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. PFS was compared between the everolimus + exemestane combination therapy with the everolimus monotherapy.
| Arm | Type | Description |
|---|---|---|
| Chemotherapy with docetaxel | EXPERIMENTAL | dual HER2-targeted therapy with Herceptin® (trastuzumab) and Perjeta® (pertuzumab) plus docetaxel. Up to three weeks after completion of chemotherapy, patients will be treated with maintenance endocrine therapy plus dual HER2-targeted therapy and Kisqali® (Ribociclib). |
| Chemotherapy with paclitaxel | EXPERIMENTAL | dual HER2-targeted therapy with Herceptin® (trastuzumab) and Perjeta® (pertuzumab) plus paclitaxel.Up to three weeks after completion of chemotherapy, patients will be treated with maintenance endocrine therapy plus dual HER2-targeted therapy and Kisqali® (Ribociclib). |
| Chemotherapy with vinorelbine | EXPERIMENTAL | dual HER2-targeted therapy with Herceptin® (trastuzumab) and Perjeta® (pertuzumab) plus vinorelbine. Up to three weeks after completion of chemotherapy, patients will be treated with maintenance endocrine therapy plus dual HER2-targeted therapy and Kisqali® (Ribociclib). |
| Chemotherapy with capecitabine | EXPERIMENTAL | dual HER2-targeted therapy with Herceptin® (trastuzumab) and Perjeta® (pertuzumab) plus capecitabine. Up to three weeks after completion of chemotherapy, patients will be treated with maintenance endocrine therapy plus dual HER2-targeted therapy and Kisqali® (Ribociclib). |
| endocrine therapy with exemestane | EXPERIMENTAL | dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus exemestane. |
| endocrine therapy with fulvestrant | EXPERIMENTAL | dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus fulvestrant. |
| endocrine therapy with anastrozole | EXPERIMENTAL | dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus anastrozole. |
| endocrine therapy with letrozole | EXPERIMENTAL | dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus letrozole. |
| Chemotherapy with nab-Paclitaxel | EXPERIMENTAL | dual HER2-targeted therapy with Herceptin® (trastuzumab) and Perjeta® (pertuzumab) plus nab-Paclitaxel. Up to three weeks after completion of chemotherapy, patients will be treated with maintenance endocrine therapy plus dual HER2-targeted therapy and Kisqali® (Ribociclib). |
| Chemotherapy with eribulin | EXPERIMENTAL | dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus eribulin. Up to three weeks after completion of chemotherapy, patients will be treated with maintenance endocrine therapy plus dual HER2-targeted therapy and Kisqali® (Ribociclib). |
| endocrine therapy with leuprorelin | EXPERIMENTAL | dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus leuprorelin. |
| endocrine therapy with goserelin | EXPERIMENTAL | dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus goserelin. |
| Lapatinib plus capecitabine | EXPERIMENTAL | Lapatinib 1250 mg once daily and capecitabine 2000mg/m2/day, days 1-14, every 21 days |
| Trastuzumab plus capecitabine | ACTIVE_COMPARATOR | trastuzumab loading dose of 8mg/kg followed by 6mg/kg q3weekly infusions, and capecitabine 2500mg/m2/day, days 1-14, every 21 days |
| Ribociclib 600 mg | EXPERIMENTAL | Combination of non-steroidal aromatase inhibitor: NSAI (letrozole or anastrozole) + goserelin + ribociclib. 1. Ribociclib (600 mg) was dosed orally for the first 21 days out of a 28-day cycle. 2. Letrozole (2.5 mg) or anastrozole (1 mg) were dosed orally daily (28 days out of the 28-day cycle). 3. Goserelin (3.6 mg) was continuously released via a subcutaneous implant injected on Day 1 of each 28-day cycle (regardless of ribociclib treatment cycle) with an administration window of + 3 days. |
| Combination Chemotherapy | ACTIVE_COMPARATOR | Combination chemotherapies of docetaxel/capecitabine, paclitaxel/gemcitabine or capecitabine/vinorelbine were administered to patients enrolled in the control group. The chemotherapy regimen was decided by the treating physician. |
| Capecitabine 1250 mg/m2 | EXPERIMENTAL | Capecitabine (1250 mg/m2 twice daily) for two weeks, followed by one week rest period in 3-weeks cycles (investigational arm). |
| Everolimus 10 mg | EXPERIMENTAL | Everolimus (10 mg daily) (investigational arm). |
| Everolimus 10 mg + Exemestane 25 mg | ACTIVE_COMPARATOR | Everolimus (10 mg daily) with Exemestane (25 mg daily) (control arm). |
| XELOX-A-Ev | EXPERIMENTAL | - |
| A | EXPERIMENTAL | Xeloda plus gleevec |
| Name | Type | Description |
|---|---|---|
| pertuzumab | DRUG | HER2 targeted Therapy |
| Trastuzumab | DRUG | HER2 targeted Therapy |
| Capecitabine | DRUG | Chemotherapy |
| Paclitaxel | DRUG | Chemotherapy |
| Vinorelbine | DRUG | Chemotherapy |
| Docetaxel | DRUG | Chemotherapy |
| Exemestane | DRUG | endocrine therapy |
| Letrozole | DRUG | endocrine therapy |
| Anastrozole | DRUG | endocrine therapy |
| Fulvestrant | DRUG | endocrine therapy |
| Ribociclib | DRUG | CDK 4/6 inhibitor |
| nab-Paclitaxel | DRUG | chemotherapy |
| eribulin | DRUG | chemotherapy |
| leuprorelin | DRUG | endocrine therapy |
| goserelin | DRUG | endocrine therapy |
| lapatinib | DRUG | oral medication; daily dose taken once a day |
| Docetaxel / Capecitabine | COMBINATION_PRODUCT | Docetaxel (IV Infusion) / Capecitabine (Tablets for oral use): Docetaxel once, on day 1 of the 3-weeks cycle. Capecitabine twice daily, on Days 1 to 14, followed by a 1-week rest period, in 3 weeks cycle. Docetaxel (60 - 75 mg/m²)/capecitabine (1600 - 2500 mg/m²/day) |
| Capecitabine / Vinorelbine | COMBINATION_PRODUCT | Capecitabine (Tablets for oral use) / Vinorelbine (Capsule for Oral use/IV infusion ). Capecitabine twice daily on day 1 to 14, followed by a 1-week rest period, in 3 weeks cycle. Vinorelbine, once, on Day 1 and Day 8 in 3 weeks cycles. Capecitabine (1600 - 2500 mg/m2/day)/vinorelbine (60 to 80 mg/m2/day \[oral\] or (25 to 30 mg/m2 \[IV infusion\] |
| Paclitaxel / Gemcitabine | COMBINATION_PRODUCT | Paclitaxel (IV Infusion) / Gemcitabine (IV Infusion): Paclitaxel via 3-hour intravenous (IV) infusion on Day 1 in 3-weeks cycles, OR Paclitaxel via 1 hour intravenous (IV) infusion on Day 1 and day 8- in 3-weeks cycles. Gemcitabine at via 30 minute IV infusion on Day 1 and Day 8 in 3 weeks cycles. Paclitaxel (175 mg/m2) (on Day 1 in 3-weeks cycles)/ gemcitabine (1000 - 1250 mg/m2) OR Paclitaxel (80 - 90 mg/m2) (on Day 1 and Day 8 in 3-weeks cycles) / gemcitabine (800 - 1250 mg/m2) |
| Letrozole OR Anastrozole | DRUG | Letrozole: Dose: 2.5 mg All days of every cycle without interruption). Tablets for oral use Anastrozole: dose: 1 mg All days of every cycle without interruption. Tablets for oral use The NSAI (letrozole or anastrozole) will be decided by the treating physician. |
| Everolimus | DRUG | Everolimus, 5 mg tablets for oral use, 10 mg (2 x 5 mg) per day (centrally supplied) |
| capecitabine/oxaliplatin/bevacizumab/RAD001 (XELOX-A-Ev) | DRUG | bevacizumab IV, capecitabine oral, oxaliplatin IV, RAD001 oral |
| capecitabine, imatinib mesylate | DRUG | Capecitabine and imatinib mesylate will both be taken by mouth twice a day |
Inclusion criteria: * Signed, written informed consent in study participation * The primary tumor and/or biopsies from metastatic sites or locoregional recurrences have been confirmed as HER2-positive (FISH-positive or IHC 3+) and hormone receptor positive breast cancer by histopathology according ...
Capecitabine is an oral chemotherapy drug studied in breast cancer, colon cancer, metastatic breast cancer, brain metastases, and unspecified adult solid tumors. It is used in both early and advanced treatment settings, often in combination with other agents such as oxaliplatin, bevacizumab, vinorelbine, or everolimus, depending on the tumor type and treatment line.
Capecitabine targets thymidylate synthase (TYMS). It is a small-molecule inhibitor that interferes with DNA synthesis by blocking this enzyme, which is essential for thymidine nucleotide production. This mechanism inhibits tumor cell proliferation and is the basis for its use across several cancer types.
Capecitabine is developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor of the clinical trials evaluating capecitabine in breast cancer and other solid tumors.
Capecitabine is in Phase 2 development as an investigational agent for the indications listed. It is not approved for these uses. The clinical program includes Phase 1, Phase 2, and Phase 3 trials, with one trial currently active and not recruiting and others completed.
Capecitabine has been studied in several trials, including NCT03839823, a Phase 2 study comparing ribociclib plus goserelin with chemotherapy in premenopausal or perimenopausal patients with advanced or metastatic breast cancer, and NCT02344472, a Phase 3 trial in metastatic breast cancer. Other trials include NCT01783444 and NCT00849550.
No, capecitabine and imatinib are different drugs. Capecitabine is a small-molecule TYMS inhibitor developed by Novartis for breast cancer, colon cancer, and other solid tumors. Imatinib is a separate agent. Capecitabine is also known by various combination regimen names, such as XELOX-A-Ev and capecitabine plus vinorelbine.