TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02517320

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MT-3995 Low

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MT-3995 Middle

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MT-3995 High

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Study: NCT04939792

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vitamin D
Description: Capsules ingested orally

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Capsule ingested orally

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vitamin D + L-cysteine
Description: Capsule ingested orally

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: L-cysteine
Description: Capsule ingested orally
Study: NCT05113992

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: aromatherapy massage
Description: In the intervention group, 4% massage oil (3 ml jojoba fixed oil, 2% Frankincense and 2% Myrrh essential oil mixture) was applied on the skin on the forearm

Intervention type: OTHER
Group type: SHAM_COMPARATOR
Intervention: classic massage
Description: In the placebo massage group, jojoba fixed oil was applied to the skin on the forearm.
Study: NCT02924012

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: video game active
Description: The session lasted 40 minutes. The participants held an active video game session. At the end they were monitored for 60 minutes at rest.

Intervention type: OTHER
Group type: OTHER
Intervention: sedentary video game
Description: The session lasted 40 minutes. The participants held an sedentary video game session, using the traditional joystick. At the end they were monitored for 60 minutes at rest.

Intervention type: OTHER
Group type: OTHER
Intervention: walking
Description: The session lasted 40 minutes. The participants held a walk using the treadmill. At the end they were monitored for 60 minutes at rest.
Study: NCT03507738

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: MT-5625 low dose
Description: Intramuscular injection

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: MT-5625 middle dose
Description: Intramuscular injection

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: MT-5625 middle dose
Description: Intramuscular injection

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: MT-5625 middle dose
Description: Intramuscular injection

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: MT-5625 high dose
Description: Intramuscular injection

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: MT-5625 high dose
Description: Intramuscular injection

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: MT-5625 high dose
Description: Intramuscular injection

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Rotarix
Description: Oral administration

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Intramuscular injection

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Intramuscular injection

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Intramuscular injection

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Intramuscular injection

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Intramuscular injection

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Intramuscular injection

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Intramuscular injection
Study: NCT02421679

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TNX-102 SL
Description: TNX-102 Sublingual tablets
Study: NCT02458183

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: DTaP-IPV combination vaccine
Description: 0.5-mL IM

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: DTaP vaccine and IPV vaccine
Description: 0.5-mL IM
Study: NCT02237261

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bendamustine, Bortezomib, Prednisone
Description: Cycle 1 (d1-42) - Induction:~Bortezomib: 1.3 mg/m2 s.c.: d1, 4, 8, 11, 22, 25, 29, 32 Bendamustine: 90 mg/m2 iv, d1, 2 Prednison: : 60 mg/m2 po,, d1-4~Cycle 2-9 (d1-28) - Consolidation:~Bortezomib: 1.3 mg/m2 s.c.: d1, 8, 15, 22 Bendamustine: 90 mg/m2 iv: d1, 2 Prednison: 60 mg/m2 po: d1-4
Study: NCT02389439

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pyronaridine-artesunate
Study: NCT00048100

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Apheresis
Description: Apheresis for T-Cell collection

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Stem Cell Transplant
Description: Stem cell or marrow infusions of allogeneic donor lymphocytes activated by acute leukemia derived dendritic cells (DC/ADL).
Study: NCT01973556

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Pharmacist-Physician Collaborative Medication Therapy Management
Study: NCT04368793

Intervention type: BEHAVIORAL
Intervention: Remote pulmonary rehabilitation
Description: The pulmonary rehabilitation intervention includes respiratory exercise, barehanded aerobic training, exercise prescription of elastic band impedance training, respiratory muscle strength training, etc.
Study: NCT03067623

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PRP
Description: PRP intrauterine infusion

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Tomcat catheter
Description: PRP intrauterine infusion by means Tomcat catheter
Study: NCT02670668

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Mutation analysis

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Mutation analysis
Study: NCT02708355

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Esomeprazole 20 mg
Description: Esomeprazole 20 mg banded capsules (22.3 mg esomeprazole magnesium trihydrate)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Esomeprazole 20 mg
Description: Esomeprazole 20 mg banded capsules (22.3 mg esomeprazole magnesium trihydrate)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Placebo capsules

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo capsules
Study: NCT02034461

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Utah Slanted Electrode Array
Description: Microelectrode slanted arrays with a large number of electrodes will be surgically implanted into peripheral nerves of patients with limb amputations or peripheral nerve trauma.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Utah Slanted Electrode Array
Description: Microelectrode slanted arrays with a large number of electrodes will be surgically implanted into peripheral nerves of patients with limb amputations or peripheral nerve trauma.
Study: NCT03254186

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Propranolol Hydrochloride
Description: Propranolol is started 10 mg tablet twice per day per oral, two week up-titration to reach a total dose of 20mg per oral four times per day over the first two weeks, then will remain on a stable dose for six weeks.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo Oral Tablet
Description: Identical placebo is started one tablet twice per day per oral, increase over the first two weeks to reach one tablet four times per day, then will remain on this dose for six weeks.
Study: NCT02664909

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Tranexamic Acid

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo (saline)
Study: NCT03214159

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ritonavir Tablet 100mg
Description: Ritonavir Tablet 100mg is a generic product manufactured by Ascletis Pharmaceutical Co., Ltd.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ritonavir Tablet 100mg
Description: Ritonavir Tablet 100mg is a generic product manufactured by Ascletis Pharmaceutical Co., Ltd.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: NORVIR tablet 100mg
Description: NORVIR Tablet is a generic product manufactured by AbbVie. NORVIR Tablet 100mg will be used as a comparator drug for the BE study.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: NORVIR tablet 100mg
Description: NORVIR Tablet is a generic product manufactured by AbbVie. NORVIR Tablet 100mg will be used as a comparator drug for the BE study.
Study: NCT00323492

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Truvada
Description: Truvada + NNRTI or PI.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Truvada
Description: Truvada + NNRTI or PI.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Truvada
Description: Truvada + NNRTI or PI.
Study: NCT03032549

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: RTD
Description: Ready to Drink Supplement

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo
Study: NCT02500446

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: dolutegravir
Description: Each film-coated tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir.
Study: NCT03647449

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Juice
Description: Participants will be drinking 800-900 kcal/day in cold-pressed juices.
Study: NCT02500446

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: A film-coated tablet identical in appearance to the active drug tablet but not containing any dolutegravir or any other active ingredient
Study: NCT04147806

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: IGRT 45 Gy in 5 fractions of 9 Gy
Description: Administration of 9 Gy in five consecutive days, to a total dose of 45 Gy radiation

Intervention type: RADIATION
Group type: ACTIVE_COMPARATOR
Intervention: IGRT 45 Gy in 5 fractions of 9 Gy
Description: Administration of 9 Gy in five consecutive days, to a total dose of 45 Gy radiation

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: IGRT 24 Gy single dose
Description: Administration of a single dose of 24 Gy in one session

Intervention type: RADIATION
Group type: ACTIVE_COMPARATOR
Intervention: IGRT 24 Gy single dose
Description: Administration of a single dose of 24 Gy in one session

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Description: 4 mg by mouth on treatment days only

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Dexamethasone
Description: 4 mg by mouth on treatment days only

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Tamsulosin
Description: 0.4 mg by mouth daily starting the day of simulation and until 2 weeks post-treatment.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Tamsulosin
Description: 0.4 mg by mouth daily starting the day of simulation and until 2 weeks post-treatment.
Study: NCT00235287

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Candesartan and enalapril
Description: 24 weeks of treatment with Candesartan in incremental doses (4,8,16 mg), where Enalapril is added in incremental doses (5,10 and 20 mg)the last 8 weeks.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: candesartan and enalapril
Description: 24 weeks of treatment with Enalapril in incremental doses (5, 10, 20 mg), where Candesartan is added in incremental doses (4,8,16 mg) in the last 8 weeks.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: candesartan and enalapril
Description: 8 weeks of treatment with Candesartan in incremental doses (4,8,16 mg), followed by 8 weeks of treatment with Enalapril in incremental doses (/5,10,20 mg). The treatment in the last 8 out of the 24 weeks is a combination of Candesartan in incremental doses (4,8,16 mg) and Enalapril 20 mg.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: candesartan and enalapril
Description: 8 weeks of treatment with Enalapril in incremental doses (5,10,20 mg), followed by 8 weeks of treatment with Candesartan (4,8,16 mg). The treatment in the last 8 out of the 24 weeks is a combination of Candesartan 16 mg and Enalapril in incremental doses (5,10,20 mg)
Study: NCT01174173

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ranolazine
Description: ranolazine 1000 mg PO BID for 3 months
Study: NCT02027948

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: nutritional and functional assessments
Description: Patients will undergo nutritional \& functional assessments along the continuum of their chemoradiotherapy treatment. The initial assessment will be measurements of height, weight, \& baseline weight loss. Patients will receive chemotherapy \& radiation as per standard practice at MSKCC, which is induction chemotherapy for approximately 3 weeks, followed by concurrent chemoradiotherapy. A commonly used regimen is weekly carboplatin (AUC 2) with paclitaxel (50 mg/m2) \& radiation consisting of 5040 cGy over 28 fractions. Patients in this study will undergo assessments at three time points (at baseline, after induction chemotherapy, \& post-treatment.) At baseline, all patients will complete the functional assessment, dysphagia scale, \& Mini- Nutritional Assessment (MNA). According to the baseline MNA score, patients will be categorized as normal nutrition, at risk for malnutrition, or malnourished \& receive the appropriate intervention.
Study: NCT03391414

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: sodium chloride
Description: 7% sodium chloride inhaled
Study: NCT01896245

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: sevoflurane 1,0
Description: anesthesia induction with propofol, remifentanil, and sevoflurane 1,0 MAC; afterwards tracheal intubation
Study: NCT00323492

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Current HAART regimen
Description: Maintain baseline regimen
Study: NCT03082599

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Presbyopia and astigmatism correcting intraocular lens
Description: The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Presbyopia and astigmatism correcting intraocular lens
Description: The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism.
Study: NCT04926532

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Toripalimab
Description: Toripalimab is a humanized anti-PD-1 monoclonal antibody

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sorafenib
Description: Sorafenib is a multi-kinase inhibitor
Study: NCT00363779

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclosporine
Description: An oral preparation given every 12 hours, 5-10 mg/kg/day in divided doses. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml. Levels will be checked twice weekly and once the patient has achieved steady state levels they shall be monitored once every 2 weeks. These therapeutic levels shall be maintained for 3 months.

Intervention type: GENETIC
Group type: EXPERIMENTAL
Intervention: Gene expression analysis
Description: A permutation test will be performed to examine whether the overall expression profile changes due to treatment. This will be done by comparing the number of significant genes to the distribution of this number if in fact there is no difference between pre-treatment and post-treatment gene expression.

Intervention type: GENETIC
Group type: EXPERIMENTAL
Intervention: Microarray analysis
Description: Gene expression profiling will be carried out on Affymetrix microarrays to compare pretreatment and posttreatment samples.
Study: NCT03647449

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Juice
Description: Participants will be drinking 800-900 kcal/day in cold-pressed juices.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Caloric restriction via Plant-based meals
Description: Participants' caloric intake will be limited to 800-900 kcal/day.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Caloric restriction via Plant-based meals
Description: Participants' caloric intake will be limited to 800-900 kcal/day.

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Plant-based meal
Description: Participants will be eating \~900 kcal/day in pre-prepared plant-based meals.
Study: NCT03155399

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Proprioceptive based training (PBT)
Description: During the PBT patient will stay in supine position with the upper limbs positioned in symmetric posture. He/She will be asked to move both limbs with the same frequency performing bilateral flexion-extension of one of the upper limb districts according to the available free ROM of the target joint. The movement execution of the affected arm will be supported by the physiotherapist performing passive movement at the same rhythm, as the one executed with the unaffected side. Patient will be asked to focus the attention on the movement performed against gravity, which will be reinforced by a verbal command. Afterwards, the physiotherapist will fully support movement execution coherently with the patient's movement initialization. The active movement performed voluntarily by the patient with unaffected limb will be considered as the reference movement, that the physiotherapist has to emulate passively, by synchronization of passive movement executed in phase with the affected side.

Intervention type: OTHER
Group type: OTHER
Intervention: Conventional neuromotor treatment (CNT).
Description: The patients randomized to the CNT group will be asked to perform exercises for postural control, exercises for hand pre-configuration, exercises for the stimulation of manipulation and functional skills, exercises for proximal-distal coordination. All the exercises will be performed with or without the assistance of a physiotherapist. The upper limb motricity will be trained with progressive complexity.
Study: NCT01542983

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Brief behavioral treatment for insomnia and bright light
Description: daily bright light exposure; 2 sessions for insomnia

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: treatment as usual
Description: Standard treatment for fatigue and insomnia
Study: NCT01042132

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: the effect of delayed intramedullary reaming
Description: in one group intramedullary reaming and nailing is performed immediately, femoral fractures in the second group are external fixated and than secondary nailed.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: the reaming of the femoral canal is performed with two different reaming devices
Description: the reaming of the femoral canal is performed with two different reaming devices; a traditional reamer (TR)and the reamer-irrigator-aspirator (RIA)
Study: NCT01381341

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: linifanib
Description: QD on Day 1 of Periods 1 and 2
Study: NCT01653106

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: cryotherapy
Description: Receive shaved ice

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: cryotherapy
Description: Receive shaved ice
Study: NCT01896245

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: sevoflurane 1,2
Description: anesthesia induction with propofol, remifentanil, and sevoflurane 1,2 MAC; afterwards tracheal intubation

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: sevoflurane 1,4
Description: anesthesia induction with propofol, remifentanil, and sevoflurane 1,4 MAC; afterwards tracheal intubation
Study: NCT05018104

Intervention type: OTHER
Intervention: This is not an interventional study
Description: This study utilizes data from the St. Paul's Hospital Peripheral Nerve Block Database.
Study: NCT00363779

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Laboratory biomarker analysis
Description: Analysis of differential gene expression profiles in patients with LGL leukemia treated with cyclosporine.
Study: NCT00913809

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Desipramine HCL 100 mg Tablets Cord Laboratories

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Norpramin 100 mg Tablets Merrell Dow Pharmaceuticals, Inc
Study: NCT03828812

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Breakfast promotion
Description: Recommendation of having breakfast daily

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Breakfast promotion
Description: Recommendation of having breakfast daily

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Nighttime snack reduction
Description: Recommendation of reducing frequency of nighttime snacking

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Nighttime snack reduction
Description: Recommendation of reducing frequency of nighttime snacking
Study: NCT01911273

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PF-03446962
Description: PF 03446962 7 mg/kg, IV, every 2 weeks, until disease progression, patient refusal or unacceptable toxicity, whichever occurs first

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Best Supportive Care
Description: BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life
Study: NCT04404647

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Irreversible electroporation
Description: The IRE procedure will be carried out as ultrasound guided technique either percutaneously or during laparotomy. Needle spacing and electrical pulse delivery will be performed in a standardized way.
Study: NCT02441933

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: taxane plus carboplatin
Description: Doxorubicin (60 mg/m2) IV + cyclophosphamide (600 mg/m2) IV every 3 weeks for 4 cycles followed by taxane plus carboplatin for 4 cycles The taxane plus carboplatin regimen can be selected based on the investigator's discretion from among the following two regimens.~* Docetaxel (75 mg/m2) IV plus carboplatin (AUC 5) IV every 3 weeks for 4 cycles~* Paclitaxel (80 mg/m2) IV weekly for 12 doses plus carboplatin (AUC 5) IV every 3 weeks for 4 cycles

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Taxane
Description: Doxorubicin (60 mg/m2) IV + cyclophosphamide (600 mg/m2) IV every 3 weeks for 4 cycles followed by taxane for 4 cycles The taxane regimen can be selected at the investigator's discretion from among the following two regimens.~* Docetaxel (75 mg/m2) IV every 3 weeks for 4 cycles~* Paclitaxel (80 mg/m2) IV weekly for 12 doses