Trial Outcomes & Findings for Arimidex/Tamoxifen Neo Adjuvant Study in Premenopausal Patients With Breast Cancer Under Anti Hormonal Treatment (NCT NCT00605267)

NCT ID: NCT00605267

Last Updated: 2012-09-06

Results Overview

The BORR were defined as the percentage of patients with confirmed CR or PR in the ITT population during 24 weeks pre-operative treatment period (based on the data from calliper measurement). CR (or PR) criteria are met at 2 or more time in points every 4 weeks. Per RECIST Criteria (V1.0) and assessed by Calliper: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 197 participants
• Primary outcome timeframe: 24 weeks
• Results posted on: 2012-09-06

Participant Flow

Participants were recruited from 4 research sites in Japan: Hakata (Fukuoka), Kumamoto (Kumamoto), Nagoya (Nagoya), Osaka (Osaka). The study initiation date was October 2007 and the study completion date was January 2010.

A total of 197 participants were recruited into this study and 98 were randomized to Anastrozole (20 mg once daily oral dose) and 99 were randomized to Tamoxifen (1 mg once daily oral dose) with one subject voluntarily discontinuing prior to receiving treatment Tamoxifen.

Participant milestones

Measure	Anastrozole 1 mg Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection	Tamoxifen 20 mg Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
Overall Study STARTED	98	99
Overall Study COMPLETED	95	90
Overall Study NOT COMPLETED	3	9

Reasons for withdrawal

Measure	Anastrozole 1 mg Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection	Tamoxifen 20 mg Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
Overall Study Adverse Event	0	1
Overall Study Lack of Efficacy	1	5
Overall Study Withdrawal by Subject	2	3

Baseline Characteristics

Arimidex/Tamoxifen Neo Adjuvant Study in Premenopausal Patients With Breast Cancer Under Anti Hormonal Treatment

Baseline characteristics by cohort

Measure	Anastrozole 1 mg n=98 Participants Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection	Tamoxifen 20 mg n=99 Participants Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection	Total n=197 Participants Total of all reporting groups
Age, Customized 20-29 years	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Age, Customized 30-39 years	21 Participants n=93 Participants	20 Participants n=4 Participants	41 Participants n=27 Participants
Age, Customized 40-49 years	65 Participants n=93 Participants	68 Participants n=4 Participants	133 Participants n=27 Participants
Age, Customized 50-59 years	10 Participants n=93 Participants	11 Participants n=4 Participants	21 Participants n=27 Participants
Sex: Female, Male Female	98 Participants n=93 Participants	99 Participants n=4 Participants	197 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: The BORR were defined as the percentage of patients with confirmed CR or PR in the ITT population during 24 weeks pre-operative treatment period. At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter

The BORR were defined as the percentage of patients with confirmed CR or PR in the ITT population during 24 weeks pre-operative treatment period (based on the data from calliper measurement).

CR (or PR) criteria are met at 2 or more time in points every 4 weeks. Per RECIST Criteria (V1.0) and assessed by Calliper: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Measure	Anastrozole 1 mg n=98 Participants Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection	Tamoxifen 20 mg n=99 Participants Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
Best Overall Response Rate (BORR) (Calliper)	70.4 Percentage of Participants	50.5 Percentage of Participants

PRIMARY outcome

Timeframe: 24 weeks

The BORR were defined as the percentage of patients with confirmed CR or PR in the ITT population during 24 weeks pre-operative treatment period (based on the data from ultra sound (US) measurement).

CR (or PR) criteria are met at 2 or more time in points every 4 weeks. Per RECIST Criteria (V1.0) and assessed by US: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Measure	Anastrozole 1 mg n=98 Participants Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection	Tamoxifen 20 mg n=99 Participants Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
Best Overall Response Rate (BORR) (US)	58.2 Participants	42.4 Participants

PRIMARY outcome

Timeframe: 24 weeks

The BORR were defined as the percentage of patients with confirmed CR or PR in the ITT population during 24 weeks pre-operative treatment period(based on the data from magnetic resonance imaging (MRI) or computed tomography (CT) measurement).

CR (or PR) criteria are met at either 12 weeks or 24 weeks. Per RECIST Criteria (V1.0) and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Measure	Anastrozole 1 mg n=98 Participants Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection	Tamoxifen 20 mg n=99 Participants Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
Best Overall Response Rate (BORR) (MRI/CT)	64.3 Percentage of Participants	37.4 Percentage of Participants

SECONDARY outcome

Timeframe: Assessed at baseline and after 24 weeks of treatment

Population: The standard BMD value is defined by Japanese Osteoporosis Society in the table of reference values showing the mean for the age, gender, race, skeletal site, and densitometer measurement units was used. Then the formula was used at each measurement data: BMD(%) = Patient's BMD / standard BMD) x 100

Change from baseline in Bone Mineral Density value (percentage), in all subjects who used DXA(Dual-energy X-ray absorptiometry) method throughout the study, at 24 weeks measured at lumbar spine.

Outcome measures

Measure	Anastrozole 1 mg n=80 Participants Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection	Tamoxifen 20 mg n=78 Participants Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
Bone Mineral Density (BMD) Lumbar Spine	-5.8 PercentageBMD=Patient's BMD/standard BMD Standard Deviation 3.4	-2.9 PercentageBMD=Patient's BMD/standard BMD Standard Deviation 2.5

SECONDARY outcome

Timeframe: Assessed at baseline and after 24 weeks of treatment

Population: Difference of percentage Bone Mineral Density (BMD) Cervical Thighbone = BMD percentage at 24 weeks - BMD percentage at baseline

Change from baseline in Bone Mineral Density value (percentage), in all subjects who used DXA(Dual-energy X-ray absorptiometry) method throughout the study, at 24 weeks measured at cervical thighbone.

Outcome measures

Measure	Anastrozole 1 mg n=80 Participants Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection	Tamoxifen 20 mg n=77 Participants Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
Bone Mineral Density (BMD) Cervical Thighbone	-2.5 PercentageBMD=Patient'sBMD/standard BMD) Standard Deviation 5.1	-0.5 PercentageBMD=Patient'sBMD/standard BMD) Standard Deviation 3.2

SECONDARY outcome

Timeframe: Assessed at baseline and after 24 weeks of treatment

Change from baseline in serum Bone-Alkaline Phosphatase (BAP) at 24 weeks measured by EIA method

Outcome measures

Measure	Anastrozole 1 mg n=59 Participants Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection	Tamoxifen 20 mg n=60 Participants Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
Bone Turnover Marker (BAP) EIA Method	7.1941 U/L Standard Deviation 6.1600	0.7333 U/L Standard Deviation 3.3640

SECONDARY outcome

Timeframe: Assessed at baseline and after 24 weeks of treatment

Change from baseline in serum Bone-Alkaline Phosphatase (BAP) at 24 weeks measured by CLEIA method

Outcome measures

Measure	Anastrozole 1 mg n=36 Participants Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection	Tamoxifen 20 mg n=30 Participants Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
Bone Turnover Marker (BAP) CLEIA Method	3.96 ug/L Standard Deviation 4.60	-0.75 ug/L Standard Deviation 3.10

SECONDARY outcome

Timeframe: Assessed at baseline and after 24 weeks of treatment

Change from baseline in serum crosslinked N-Telopeptide of type I collagen (NTX) at 24 weeks

Outcome measures

Measure	Anastrozole 1 mg n=95 Participants Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection	Tamoxifen 20 mg n=89 Participants Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
Bone Turnover Marker (NTX)	9.17 nmolBCE(Bone Collagen Equivalent) /L Standard Deviation 4.74	2.59 nmolBCE(Bone Collagen Equivalent) /L Standard Deviation 3.23

SECONDARY outcome

Timeframe: Assessed at baseline and after 24 weeks of treatment

Ratio of serum Oestrone (E1) concentration (pg/mL) in the ITT population from baseline at 24 weeks.

Outcome measures

Measure	Anastrozole 1 mg n=96 Participants Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection	Tamoxifen 20 mg n=92 Participants Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
Serum Oestrone (E1) Concentrations	0.028 Ratio Standard Deviation 0.036	0.341 Ratio Standard Deviation 0.282

SECONDARY outcome

Timeframe: Assessed at baseline and after 24 weeks of treatment

Ratio of serum Oestradiol (E2) concentration (pg/mL) in the ITT population from baseline at 24 weeks.

Outcome measures

Measure	Anastrozole 1 mg n=96 Participants Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection	Tamoxifen 20 mg n=92 Participants Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
Serum Oestradiol (E2) Concentrations	0.041 Ratio Standard Deviation 0.092	0.082 Ratio Standard Deviation 0.186

SECONDARY outcome

Timeframe: Assessed at baseline and after 24 weeks of treatment

ER status in the ITT population is categorized as Positive or Negative

Outcome measures

Measure	Anastrozole 1 mg n=94 Participants Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection	Tamoxifen 20 mg n=90 Participants Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
Oestrogen Receptor (ER) Status Baseline Positive & 24 weeks Negative	2 Participants	1 Participants
Oestrogen Receptor (ER) Status Baseline Positive & 24 weeks Positive	92 Participants	89 Participants
Oestrogen Receptor (ER) Status Baseline Negative & 24 weeks Negative	0 Participants	0 Participants
Oestrogen Receptor (ER) Status Baseline Negative & 24 weeks Positive	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Assessed at baseline and after 24 weeks of treatment

PgR status in the ITT population is categorized as Positive or Negative.

Outcome measures

Measure	Anastrozole 1 mg n=94 Participants Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection	Tamoxifen 20 mg n=90 Participants Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
Progesterone Receptor (PgR) Status Baseline Positive & 24 weeks Negative	60 Participants	19 Participants
Progesterone Receptor (PgR) Status Baseline Positive & 24 weeks Positive	29 Participants	59 Participants
Progesterone Receptor (PgR) Status Baseline Negative & 24 weeks Negative	4 Participants	9 Participants
Progesterone Receptor (PgR) Status Baseline Negative & 24 weeks Positive	1 Participants	3 Participants

SECONDARY outcome

Timeframe: Assessed at baseline and after 24 weeks of treatment

HER2 status in the ITT population is categorized as Positive or Negative

Outcome measures

Measure	Anastrozole 1 mg n=94 Participants Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection	Tamoxifen 20 mg n=90 Participants Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
Human Epidermal Growth Factor Receptor 2 (HER2) Status Baseline Negative & 24 weeks Positive	2 Participants	2 Participants
Human Epidermal Growth Factor Receptor 2 (HER2) Status Baseline Positive & 24 weeks Negative	0 Participants	0 Participants
Human Epidermal Growth Factor Receptor 2 (HER2) Status Baseline Positive & 24 weeks Positive	0 Participants	0 Participants
Human Epidermal Growth Factor Receptor 2 (HER2) Status Baseline Negative & 24 weeks Negative	92 Participants	88 Participants

SECONDARY outcome

Timeframe: Assessed at baseline and after 24 weeks of treatment

Number of patients in the ITT population defined as histopathological responders over the total number of patients x 100. An histopathological responder = a patient classified as Grade 1b, 2 or 3 for the histopathological response (Grade 0 = no response, 1a = mild response, 1b = moderate response, 2 = marked response or 3 = complete response)

Outcome measures

Measure	Anastrozole 1 mg n=98 Participants Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection	Tamoxifen 20 mg n=99 Participants Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
Histopathological Response Rate (HRR)	41.8 Percentage of Participants	27.3 Percentage of Participants

SECONDARY outcome

Timeframe: Assessed at baseline and after 24 weeks of treatment

Population: Total score of subscores or TOI is calculated from each score of question. Higher score means better and lower score means worthier. PWB, FWB and BCS were assessed in this study. TOI was a total of PWB, FWB and BCS.

Change from baseline in Functional Assessment of Cancer Therapy-Breast (FACT-B)in the ITT population at 24 weeks. Trial Outcome Index (TOI) = the sum of the Physical Well-Being (PWB), Functional Well-Being (FWB), and Breast Cancer Scale (BCS) subscales of FACT-B.

FACT-B includes 36 questions; 7 in PWB (Physical Well-Being); 7 inSWB (Social / Family Well-Being); 6 in EWB (Emotional Well-Being); 7 in FWB (Functional Well-Being); 9 in BCS (Breast Cancer Subscale).

Total score of subscores or TOI is calculated from each score of question. Higher score means better and lower score means worthier.

Score range; 0-28 in PWB; 0-28 in SWB; 0-24 in EWB; 0-28 in FWB; 0-36 in BCS; 0-92 in TOI.

Outcome measures

Measure	Anastrozole 1 mg n=95 Participants Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection	Tamoxifen 20 mg n=92 Participants Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
Functional Assessment of Cancer Therapy-Breast (FACT-B)	-4.42 Trial Outcome Index (TOI) (Prorated) Standard Deviation 11.07	-2.65 Trial Outcome Index (TOI) (Prorated) Standard Deviation 8.09

SECONDARY outcome

Timeframe: Assessed at baseline and after 24 weeks of treatment

Population: Difference of Endocrine Subscale (ES) = ES at 24 weeks - ES at baseline.

Change from baseline in Endocrine Symptom Subscale (ES)) in the ITT population at 24 weeks. ES score = the sum of the responses to all the questions on ES, low scores reflect poor quality of life and high scores reflects better quality of life.

Score range: 0-72

Outcome measures

Measure	Anastrozole 1 mg n=92 Participants Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection	Tamoxifen 20 mg n=91 Participants Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
Endocrine Subscale (ES)	-8.85 ES score Standard Deviation 8.69	-6.27 ES score Standard Deviation 8.93

SECONDARY outcome

Timeframe: Assessed at week 12

Trough Plasma concentrations (Cmin) of Anastrozole - only Anastrozole arm was evaluated for Trough Plasma concentrations.

Outcome measures

Measure	Anastrozole 1 mg n=28 Participants Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection	Tamoxifen 20 mg Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
Anastrozole Plasma Concentrations (Cmin)	29.7 ng/mL Interval 17.3 to 52.4	—

Adverse Events

Anastrozole 1 mg

Serious events: 1 serious events

Other events: 87 other events

Deaths: 0 deaths

Tamoxifen 20 mg

Serious events: 0 serious events

Other events: 84 other events

Deaths: 0 deaths

Serious adverse events

Measure	Anastrozole 1 mg n=98 participants at risk Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection	Tamoxifen 20 mg n=98 participants at risk Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign Neoplasm	1.0% 1/98 One subject voluntarily discontinued prior to receiving treatment to Tamoxifen	0.00% 0/98 One subject voluntarily discontinued prior to receiving treatment to Tamoxifen

Other adverse events

Measure	Anastrozole 1 mg n=98 participants at risk Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection	Tamoxifen 20 mg n=98 participants at risk Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
Gastrointestinal disorders Constipation	4.1% 4/98 One subject voluntarily discontinued prior to receiving treatment to Tamoxifen	13.3% 13/98 One subject voluntarily discontinued prior to receiving treatment to Tamoxifen
Gastrointestinal disorders Abdominal Pain Upper	5.1% 5/98 One subject voluntarily discontinued prior to receiving treatment to Tamoxifen	6.1% 6/98 One subject voluntarily discontinued prior to receiving treatment to Tamoxifen
General disorders Fatigue	4.1% 4/98 One subject voluntarily discontinued prior to receiving treatment to Tamoxifen	5.1% 5/98 One subject voluntarily discontinued prior to receiving treatment to Tamoxifen
Infections and infestations Nasopharyngitis	27.6% 27/98 One subject voluntarily discontinued prior to receiving treatment to Tamoxifen	24.5% 24/98 One subject voluntarily discontinued prior to receiving treatment to Tamoxifen
Musculoskeletal and connective tissue disorders Arthralgia	35.7% 35/98 One subject voluntarily discontinued prior to receiving treatment to Tamoxifen	20.4% 20/98 One subject voluntarily discontinued prior to receiving treatment to Tamoxifen
Musculoskeletal and connective tissue disorders Musculoskeletal Stiffness	21.4% 21/98 One subject voluntarily discontinued prior to receiving treatment to Tamoxifen	9.2% 9/98 One subject voluntarily discontinued prior to receiving treatment to Tamoxifen
Musculoskeletal and connective tissue disorders Joint Stiffness	5.1% 5/98 One subject voluntarily discontinued prior to receiving treatment to Tamoxifen	1.0% 1/98 One subject voluntarily discontinued prior to receiving treatment to Tamoxifen
Musculoskeletal and connective tissue disorders Myalgia	5.1% 5/98 One subject voluntarily discontinued prior to receiving treatment to Tamoxifen	1.0% 1/98 One subject voluntarily discontinued prior to receiving treatment to Tamoxifen
Nervous system disorders Headache	20.4% 20/98 One subject voluntarily discontinued prior to receiving treatment to Tamoxifen	15.3% 15/98 One subject voluntarily discontinued prior to receiving treatment to Tamoxifen
Nervous system disorders Dizziness	3.1% 3/98 One subject voluntarily discontinued prior to receiving treatment to Tamoxifen	5.1% 5/98 One subject voluntarily discontinued prior to receiving treatment to Tamoxifen
Nervous system disorders Hypoaesthesia	5.1% 5/98 One subject voluntarily discontinued prior to receiving treatment to Tamoxifen	3.1% 3/98 One subject voluntarily discontinued prior to receiving treatment to Tamoxifen
Psychiatric disorders Insomnia	7.1% 7/98 One subject voluntarily discontinued prior to receiving treatment to Tamoxifen	9.2% 9/98 One subject voluntarily discontinued prior to receiving treatment to Tamoxifen
Reproductive system and breast disorders Menopausal Symptoms	6.1% 6/98 One subject voluntarily discontinued prior to receiving treatment to Tamoxifen	4.1% 4/98 One subject voluntarily discontinued prior to receiving treatment to Tamoxifen
Reproductive system and breast disorders Metrorrhagia	5.1% 5/98 One subject voluntarily discontinued prior to receiving treatment to Tamoxifen	2.0% 2/98 One subject voluntarily discontinued prior to receiving treatment to Tamoxifen
Skin and subcutaneous tissue disorders Hyperhidrosis	4.1% 4/98 One subject voluntarily discontinued prior to receiving treatment to Tamoxifen	8.2% 8/98 One subject voluntarily discontinued prior to receiving treatment to Tamoxifen
Skin and subcutaneous tissue disorders Rash	5.1% 5/98 One subject voluntarily discontinued prior to receiving treatment to Tamoxifen	3.1% 3/98 One subject voluntarily discontinued prior to receiving treatment to Tamoxifen
Vascular disorders Hot Flush	52.0% 51/98 One subject voluntarily discontinued prior to receiving treatment to Tamoxifen	53.1% 52/98 One subject voluntarily discontinued prior to receiving treatment to Tamoxifen

Additional Information

Gerard Lynch

AstraZeneca

Email: aztrial_results_posting@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60