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FAC Versus FAC Plus Weekly Paclitaxel as Adjuvant Treatment of Node Negative High Risk Breast Cancer Patients
Phase 3 trial testing Fluorouracil in Breast Cancer in 1,925 participants. Completed in 1 October 2013.
| Lead sponsor | Spanish Breast Cancer Research Group |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1,925 |
| Start date | 19 September 2003 |
| Primary completion | 1 October 2013 |
| Estimated completion | 1 October 2013 |
| Sites | 68 locations across Spain |
Spanish Breast Cancer Research Group
Adults 18 to 70, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
DFS is defined as the evidence of local, regional or metastatic recurrence, second primary cancer (with the exception of carcinoma of squamous cells or basal cells of the skin, cervical carcinoma in situ or lobular or ductal carcinoma in situ of the breast) or death for any reason.
| Group | Value | 95% CI |
|---|---|---|
| Arm A: FAC | 98 | |
| Arm B: FAC-wP | 71 |
OS event is defined as the death from any cause.
| Group | Value | 95% CI |
|---|---|---|
| Arm A: FAC | 40 | |
| Arm B: FAC-wP | 31 |
Time frame: Through study treatment up to 30 days after last study dose; All-Cause Mortality was assessed up to 5 years.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Arm A: FAC | Arm B: FAC-wP |
|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | — | — |
| Neutropenia | Blood and lymphatic system disorders | — | — |
| Infection without neutropenia | Infections and infestations | — | — |
| Infection with grade 3 or 4 neutropenia | Infections and infestations | — | — |
| Neutropenia | Blood and lymphatic system disorders | — | — |
| Thrombosis/embolism | Cardiac disorders | — | — |
| Thrombosis/embolism | Cardiac disorders | — | — |
| Neutropenia | Blood and lymphatic system disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Fever | General disorders | — | — |
| Fatigue | General disorders | — | — |
| Catheter-related infection | Skin and subcutaneous tissue disorders | — | — |
| Wound-infectious | Infections and infestations | — | — |
| CNS cerebrovascular ischemia | Nervous system disorders | — | — |
| Fistula-rectal/anal | Gastrointestinal disorders | — | — |
| Hepatic - Hepatitis | Hepatobiliary disorders | — | — |
| Injection site reaction | Skin and subcutaneous tissue disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Gastroenteritis | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Gastrointestinal - appendicitis surgery | Gastrointestinal disorders | — | — |
| Bone Fracture | General disorders | — | — |
| Pneumonitis, refractory septic shock | Respiratory, thoracic and mediastinal disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Reaction | System | Arm A: FAC | Arm B: FAC-wP |
|---|---|---|---|
| Neutrophils/Granulocytes | Blood and lymphatic system disorders | — | — |
| Irregular Menses | Reproductive system and breast disorders | — | — |
| Leukocytes | Blood and lymphatic system disorders | — | — |
| Fatigue | General disorders | — | — |
| Neurophaty-sensory | Nervous system disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Febrile neutropenia | General disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| SGPT (ALT) | Investigations | — | — |
| STOMATITIS/PHARYNGITIS (ORAL/PHARYNGEAL MUCOSITIS) | Gastrointestinal disorders | — | — |
| Myalgia | Nervous system disorders | — | — |
| Infection without neutropenia | Infections and infestations | — | — |
| Infection with unknown ANC | Infections and infestations | — | — |
| Lymphopenia | Blood and lymphatic system disorders | — | — |
| Thrombosis/embolism | Cardiac disorders | — | — |
| DIARRHEA | Gastrointestinal disorders | — | — |
| RASH/DESQUAMATION | Skin and subcutaneous tissue disorders | — | — |
| INFECTION WITH NEUTROPENIA | Infections and infestations | — | — |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | — | — |
| DYSPNEA | Respiratory, thoracic and mediastinal disorders | — | — |
| SGOT (AST) | Hepatobiliary disorders | — | — |
| CONSTIPATION | Gastrointestinal disorders | — | — |
| HEMOGLOBIN | Blood and lymphatic system disorders | — | — |
| WEIGHT GAIN | General disorders | — | — |
| CONJUNCTIVITIS | Eye disorders | — | — |
| GGT | Hepatobiliary disorders | — | — |
| PLATELETS | Blood and lymphatic system disorders | — | — |
| NAIL CHANGES | Skin and subcutaneous tissue disorders | — | — |
| HAND FOOT SKIN REACTION | Skin and subcutaneous tissue disorders | — | — |
| MUCOSITIS | Gastrointestinal disorders | — | — |
| MOOD ALTERATION-ANXIETY, AGITATION | Nervous system disorders | — | — |
| HYPERGLYCEMIA | Metabolism and nutrition disorders | — | — |
| ALLERGIC REACTION/HYPERSENSITIVITY | Immune system disorders | — | — |
| BONE PAIN | Investigations | — | — |
| DYSPEPSIA/HEARTBURN | Gastrointestinal disorders | — | — |
| VASOVAGAL EPISODE | Cardiac disorders | — | — |
| ANOREXIA | Gastrointestinal disorders | — | — |
| COUGH | Respiratory, thoracic and mediastinal disorders | — | — |
| PNEUMONITIS/PULMONARY INFILTRATES | Infections and infestations | — | — |
| PRURITUS | Skin and subcutaneous tissue disorders | — | — |
Most-reported serious reactions: Febrile neutropenia, Neutropenia, Infection without neutropenia, Infection with grade 3 or 4 neutropenia, Neutropenia, Thrombosis/embolism, Thrombosis/embolism, Neutropenia.
Data from ClinicalTrials.gov NCT00129389 adverse events section.
This is a prospective, open-label, randomized, phase III trial. Patients will be stratified after breast surgery, as per investigational site; menopausal status; node negative diagnosis, as per sentinel-node technique versus lymphadenectomy; hormone receptor status (positive versus negative).
7 peer-reviewed publications reference this trial (live from Europe PMC):
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