TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01565538

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Erlotinib
Description: 150 mg Given orally

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pemetrexed
Description: 500mg/m2 Given IV
Study: NCT00764179

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: milk enriched in proteins (2.15 g/100ml)
Description: Neonates will drink the hyperproteinic milk until they reach the 25th of Sempé and Pedron curve (milk to be taken at least until 40 weeks of amenorrhoea or at maximum until 4 months of corrected age)

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: milk with normal protein concentration (1.45g/100ml)
Description: Neonates will drink the normoproteinic milk until they reach the 25th of Sempé and Pedron curve (milk to be taken at least until 40 weeks of amenorrhoea or at maximum until 4 months of corrected age)
Study: NCT01043731

Intervention type: PROCEDURE
Intervention: Laparoscopic transvaginal hybrid anterior resection
Description: Transvaginal Hybrid Anterior Resection: three 5mm trocars are placed transabdominally (one trans-umbilical, the other two in the lower abdomen). Identification of the inferior mesenteric vein and artery. Clipping of the vein. Then placement of a 12mm trocar through the posterior fornix of the vagina for stapling of the inferior mesenteric artery. After mobilisation of the colon descendens and the splenic flexure stapling of the proximal rectum through the 12mm trocar placed vaginally. Afterwards the colpotomy is performed and the mobilised left hemi-colon is extracted transvaginally. The proximal colonic resection is performed extracorporeally in the conventional fashion with placement of a purse-string suture and insertion of the circular stapling anvil into the proximal end of the bowel. The bowel is then replaced into the abdominal cavity. The colpotomy is then closed. A circular stapler is inserted transanally and the end-to-end anastomosis is performed.
Study: NCT03134456

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pembrolizumab Injection
Description: Pembrolizumab according to the dosage and administration in Product Information of Keytruda in Korea (2mg/kg) until it is changed to 200mg flat dose.
Study: NCT03940261

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: High Intensity Interval Training
Description: Participants will complete exercise training 3x/week for 10 weeks. Exercise will consist of 10, 1-minute cycling intervals at 90% of peak power output, each separated by 1-min at 10% peak power output.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Continuous Moderate Intensity Training
Description: Participants will complete exercise training 3x/week for 10 weeks. Exercise will consist of 30-50 minutes of cycling at 60% peak power output.
Study: NCT02655692

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ketamine
Description: FDA approved anesthetic medication with rapid acting antidepressant effects.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ketamine
Description: FDA approved anesthetic medication with rapid acting antidepressant effects.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo/Saline
Description: This is a saline placebo/non-active solution.
Study: NCT01394770

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Aliskiren
Description: Aliskiren 150 mg for 1 month with forced uptitration to 300 mg compared in parallel group with amlodipine 5 mg with forced uptitration to 10 mg

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Aliskiren
Description: Aliskiren 150 mg for 1 month with forced uptitration to 300 mg compared in parallel group with amlodipine 5 mg with forced uptitration to 10 mg
Study: NCT03959709

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: immediate acellular dermal matrix-assisted implant-based breast reconstruction with prepectoral implant placement.
Description: On the day of surgery, after the completion of the mastectomy, the vascularity of the mastectomy flaps will be evaluated, and debridement is performed where necessary. A temporary implant sizer is placed in the pocket to assess the position and shape of the prepectoral pocket. The pocket is adjusted where necessary. A sheet of ADM (DermAcell) is then selected. The DermAcell will be prepared as per the manufacture's instructions and fenestrated using size 11 blade. The DermACELL piece will be trimmed to the appropriate shape and sutured to the superior medial and lateral edges of the pectoralis major muscle. The inferior edge will be sutured to the fascia at the level of the inframammary fold. Two closed suction drains will be placed (one below the mastectomy skin flap, and one below DermACELL). The implant will be inserted to the pre-pectoral pocket and several anchor sutures will be used to secure the superior-medial edge of DermACELL to mastectomy flap.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Immediate acellular dermal matrix-assisted implant-based breast reconstruction with subpectoral implant placement
Description: On the day of surgery, after the completion of the mastectomy, the vascularity of the mastectomy flaps will be evaluated, and debridement is performed where necessary. The reconstructive operative procedure will then proceeded with (1) elevation of the pectoralis major muscle with release of inferior attachments; (2) placement of implant subpectorally; (3) placement and suturing of DermACELL to constitute the inferolateral breast pocket; (4) placement of two closed suction drains (one superiorly between the pectoralis major and skin, and one inferiorly between the DermACELL and skin); (5) removal of sizer and placement of permanent to the pocket and (6) suture the inferior edge of DermACELL to the inferior edge of the pectoral major muscle. The skin will be closed and the dressing will be applied as standard protocol.
Study: NCT02339727

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Preterm infants formula
Description: The group 1 of children will receive a preterm infants formula supplemented with DHA and ARA with a relationship omega 6/omega 3 = 2/1 during the first 3 months of life. And group 2 will receive other Preterm infants formula very similar, but with a ratio of DHA and AA=1/1 also during the first 3 months of life.

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Preterm infants formula
Description: The group 1 of children will receive a preterm infants formula supplemented with DHA and ARA with a relationship omega 6/omega 3 = 2/1 during the first 3 months of life. And group 2 will receive other Preterm infants formula very similar, but with a ratio of DHA and AA=1/1 also during the first 3 months of life.
Study: NCT00690456

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rimonabant
Description: Tablet, oral administration

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo (for Rimonabant)
Description: Tablet, oral administration

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Metformin
Description: Metformin continued at stable dose as background therapy

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Metformin
Description: Metformin continued at stable dose as background therapy
Study: NCT03961256

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Exenatide SR
Description: Exenatide SR 2 mg subcutaneous (SQ) weekly
Study: NCT01334541

Intervention type: BEHAVIORAL
Intervention: SAFE VET
Description: All SAFE VET EDs provide a standardized intervention that is specifically adapted for use in the ED to mitigate suicide risk. Given that the SAFE VET intervention was developed for use in a busy ED setting, the length of the intervention is approximately 45 minutes. The SAFE VET intervention is administered by a clinical provider who has been specifically trained and consists of:~1. Risk Assessment~2. Safety Planning Intervention: Developed by Stanley and Brown (2008), Safety Planning Intervention consists of a hierarchically-arranged list of coping strategies identified for use during a subsequent suicidal crisis.~3. Clinical Follow-Up Protocol
Study: NCT02391909

Intervention type: BIOLOGICAL
Intervention: Vivotif

Intervention type: BIOLOGICAL
Intervention: Vivotif
Study: NCT02153788

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Temazepam
Description: Temazepam 15 mg orally at bedtime

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Study: NCT03132454

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Decitabine
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Description: Given IV or PO

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Palbociclib
Description: Given PO

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Palbociclib
Description: Given PO

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Palbociclib
Description: Given PO

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sorafenib
Description: Given PO
Study: NCT03470961

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Anti-Thymocyte Globulins
Description: Induction therapy regimen in simultaneous pancreas kidney transplantation
Study: NCT00530374

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Oral Iron Supplement
Description: Iron Sprinkles are provided as a powder in a single-dose sachet to be taken once daily for 60 days

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo Sprinkles are provided as a powder in a single-dose sachet to be taken once daily for 60 days
Study: NCT01730417

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: no carrier added metaiodobenzylguanidine
Description: Sequential imaging was performed to determine radiation dosimetry of high specific activity 123I-mIBG
Study: NCT00049517

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: sargramostim
Description: Given IV or as an injection

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: sargramostim
Description: Given IV or as an injection

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: sargramostim
Description: Given IV or as an injection

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: sargramostim
Description: Given IV or as an injection

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: busulfan
Description: Given IV
Study: NCT00162682

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Antiretroviral Drug Combination Switching Criteria
Description: Antiretroviral treatment will use the standard viral load (VL) based monitoring strategy, where switching is performed when VL is confirmed (within one month) above 400 copies per mL.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Antiretroviral Drug Combination Switching Criteria
Description: Antiretroviral treatment is monitored using a CD4 based monitoring strategy where switching is performed when a confirmed (within one month) relative decline in CD4 count of more than 30% from peak values is observed within 200 cells from baseline.
Study: NCT00176891

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Stem Cell Transplant
Description: enzyme replacement 10-12 weeks prior to hematopoietic stem cell transplant (HSCT), and 8 weeks following
Study: NCT03411044

Intervention type: DEVICE
Intervention: Fitmore Hip Stem
Study: NCT03453541

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ketorolac Tromethamine
Description: Ketorolac Tromethamine 0.5 mg/kg IV up to a maximum dose of 30mg, in the form of Ketorolac Tromethamine solution for IV/IM use 30mg/ml single dose vial at the completion of the tonsillectomy in the operating room.
Study: NCT00049517

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: busulfan
Description: Given IV
Study: NCT01680406

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Primaquine
Study: NCT03453541

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: 0.9% Normal Saline
Description: 0.9 % Normal saline 1ml/60kg up to a maximum dose of 1ml IV bolus (an equivalent volume as per kg Ketorolac Trimethamine dose) at the completion of the tonsillectomy in the operating room.
Study: NCT01680406

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Primaquine

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Chloroquine

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Chloroquine
Study: NCT00176891

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Laronidase ERT
Description: Laronidase ERT will be administered 10-12 weeks prior to HSCT, and 8 weeks following.
Study: NCT01691586

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Remote patient monitoring
Description: Remote monitoring of ICD and heart failure data

Intervention type: OTHER
Group type: OTHER
Intervention: In-Clinic check-ups
Description: Calender-based In-Clinic ICD check-up

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: In-Clinic check-ups
Description: Calender-based In-Clinic ICD check-up
Study: NCT04815460

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: High intensity-interval training (HIIT)
Description: Subjects performed HIIT (3-min intervals at 40% and 80%VO2peak) on a bicycle ergometer for 30 min/day, 5 days/week for 6 weeks.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Moderate intensity-continuous (MICT)
Description: Subjects performed MICT (sustained 60%VO 2max) on a bicycle ergometer for 30 min/day, 5 days/week for 6 weeks.
Study: NCT01129323

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide, Fludarabine, Rabbit ATG
Description: Fludarabine 30mg/m2/dose IV and cyclophosphamide 10mg/kg/dose IV are given once per day from day -5 to -2. rATG 1.5 mg/kg/dose IV is given from day -4 to -1.
Study: NCT00049517

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: busulfan
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: busulfan
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: cyclophosphamide
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: cyclophosphamide
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: cyclophosphamide
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: cyclophosphamide
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: cytarabine
Description: Given as a continuous infusion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: cytarabine
Description: Given as a continuous infusion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: cytarabine
Description: Given as a continuous infusion

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: cytarabine
Description: Given as a continuous infusion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: cytarabine
Description: Given as a continuous infusion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: cytarabine
Description: Given as a continuous infusion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: gemtuzumab ozogamicin (GO)
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: gemtuzumab ozogamicin (GO)
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Daunorubicin
Description: Given intravenously daily for 3 days at a dose of either 45 or 90 mg/m2.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Daunorubicin
Description: Given intravenously daily for 3 days at a dose of either 45 or 90 mg/m2.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Daunorubicin
Description: Given intravenously daily for 3 days at a dose of either 45 or 90 mg/m2.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Daunorubicin
Description: Given intravenously daily for 3 days at a dose of either 45 or 90 mg/m2.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Daunorubicin
Description: Given intravenously daily for 3 days at a dose of either 45 or 90 mg/m2.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Daunorubicin
Description: Given intravenously daily for 3 days at a dose of either 45 or 90 mg/m2.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Autologous HCT
Description: Autologous hematopoietic cell transplantation

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Autologous HCT
Description: Autologous hematopoietic cell transplantation

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Autologous HCT
Description: Autologous hematopoietic cell transplantation
Study: NCT01160445

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Zanolimumab
Description: 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Zanolimumab
Description: 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Aldesleukin
Description: 720,000 IU/kg every 8 hours for a maximum of 15 doses.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Aldesleukin
Description: 720,000 IU/kg every 8 hours for a maximum of 15 doses.
Study: NCT03225352

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 500 mg acetylsalicylic acid (Aspirin, BAYE4465)
Description: Single intake of 1 tablet, 500mg

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 500 mg acetylsalicylic acid (Aspirin, BAYE4465)
Description: Single intake of 1 tablet, 500mg

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 500 mg acetylsalicylic acid (Aspirin, BAYE4465)
Description: Single intake of 1 tablet, 500mg

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 500 mg acetylsalicylic acid (Aspirin, BAYE4465)
Description: Single intake of 1 tablet, 500mg

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 1000 mg acetylsalicylic acid (Aspirin, BAYE4465)
Description: Single intake of 1 tablet, 1000mg

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 1000 mg acetylsalicylic acid (Aspirin, BAYE4465)
Description: Single intake of 1 tablet, 1000mg
Study: NCT00049517

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Autologous HCT
Description: Autologous hematopoietic cell transplantation

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Allogeneic HCT
Description: Allogeneic hematopoietic cell transplantation

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Allogeneic HCT
Description: Allogeneic hematopoietic cell transplantation
Study: NCT03044769

Intervention type: PROCEDURE
Intervention: Malformations resection
Description: Resection of the malformation lung sections with a healthy adjacent part
Study: NCT03225352

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 1000 mg acetylsalicylic acid (Aspirin, BAYE4465)
Description: Single intake of 1 tablet, 1000mg

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 1000 mg acetylsalicylic acid (Aspirin, BAYE4465)
Description: Single intake of 1 tablet, 1000mg

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 400 mg ibuprofen(Nurofen)
Description: Single intake of 1 tablet, 400mg

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 400 mg ibuprofen(Nurofen)
Description: Single intake of 1 tablet, 400mg

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 400 mg ibuprofen(Nurofen)
Description: Single intake of 1 tablet, 400mg

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 400 mg ibuprofen(Nurofen)
Description: Single intake of 1 tablet, 400mg
Study: NCT04521777

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Exercise Intervention
Description: Participate in an 8-week home-based strengthening and walking program
Study: NCT03225352

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 400 mg ibuprofen (Dolormin Extra)
Description: Single intake of 1 tablet, 400mg
Study: NCT04521777

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Physical Performance Testing
Description: Complete a physical function test

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Questionnaire Administration
Description: Ancillary studies
Study: NCT00449748

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: RAD001 (Everolimus)
Description: Oral RAD001 10 mg daily for 30 days
Study: NCT00277797

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Biowave Targeted Non-Invasive Electronic Pain Control Device
Description: This device is a non-invasive non-pharmacologic treatment for pain. It sends a premixed modulated envelope of two high frequency electronic wave forms (Feed Signals) between two electrodes.

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Biowave Targeted Non-Invasive Electronic Pain Control Device
Description: This device is a non-invasive non-pharmacologic treatment for pain. It sends a premixed modulated envelope of two high frequency electronic wave forms (Feed Signals) between two electrodes.

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: TENS (Transcutaneous Electrical Nerve Stimulation) device
Description: This device features a bisourced, biphasic waveform. The combined constant voltage, constant-current waveform provides a strong stimulus that allows the clinician to prescribe a treatment program.

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: TENS (Transcutaneous Electrical Nerve Stimulation) device
Description: This device features a bisourced, biphasic waveform. The combined constant voltage, constant-current waveform provides a strong stimulus that allows the clinician to prescribe a treatment program.
Study: NCT03699683

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Combined aerobic and resistance training program
Study: NCT04060862

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ipatasertib
Description: Phase 1b: Ipatasertib, 300 mg starting dose administered orally once daily (PO QD) during an initial 5-7 day run-in period, then continued on Days 1-21 during the first cycle. Starting with Cycle 2, Day 1 ipatasertib will be taken orally once daily on Days 1-21 of each 28-day cycle. Phase 3: Ipatasertib, administered PO QD on Days 1-21 of each 28-day cycle at the dose confirmed in the Phase Ib portion.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Phase 3: Matching placebo, administered PO QD on Days 1-21 of each 28-day cycle at the dose confirmed in the Phase Ib portion.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Palbociclib
Description: Palbociclib, administered PO QD on Days 1-21 of each 28-day cycle.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Palbociclib
Description: Palbociclib, administered PO QD on Days 1-21 of each 28-day cycle.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fulvestrant
Description: Fulvestrant, 500 mg administered as two intramuscular injections of 250 mg each on Cycle 1 Days 1 and 15 and Day 1 of each subsequent 28-day cycle.
Study: NCT00256308

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Oxaliplatin
Description: 70mg/m2 IV over 120 min once a week during radiation