A Study of Trastuzumab Emtansine (T-DM1) Sequentially With Anthracycline-based Chemotherapy, as Adjuvant or Neoadjuvant Therapy for Patients With Early Stage Herceptin (HER)2-positive Breast Cancer

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01196052
• Collaborator: (none)
• Enrollment: 153
• Locations: 44
• Arm: 1
• Duration (Months): 32
• Patients Per Site: 3.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This single-arm open-label study assessed the safety, feasibility, and efficacy of trastuzumab emtansine (T-DM1) after the completion of anthracycline-based adjuvant/neoadjuvant chemotherapy in patients with early HER2-positive breast cancer. Patients received T-DM1 3.6 mg/kg intravenously on Day 1 of each 3-week cycle, for up to 17 cycles.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: Trastuzumab emtansine	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 153 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Multinational Phase II Study to Assess the Clinical Safety and Feasibility of Trastuzumab Emtansine Sequentially With Anthracycline-based Chemotherapy, as Adjuvant or Neoadjuvant Therapy for Patients With Early Stage HER2-positive Breast Cancer
• Study Start Date: Oct 1, 2010
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Trastuzumab emtansine Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.	Drug: Trastuzumab emtansine; Trastuzumab emtansine was provided as a single-use lyophilized formulation in a glass vial.; Other Names: T-DM1

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With a Cardiac Event Within 12 Weeks After the Start of Trastuzumab Emtansine Treatment [Baseline to 12 weeks after the start of trastuzumab emtansine treatment]

   A cardiac event was defined as death from a cardiac cause or severe congestive failure (New York Heart Association [NYHA] Class III or IV) with a decrease in left ventricular ejection fraction (LVEF) of ≥ 10% from Baseline to an LVEF of < 50%.

2. Adverse Events, LVEF Function, and Deaths [From the start to the end of trastuzumab emtansine treatment (up to 51 weeks)]

   The following percentages of participants are reported: At least 1 adverse event while receiving T-DM1; at least 1 serious adverse event while receiving T-DM1; an adverse event leading to discontinuation, dose delay, or dose reduction of trastuzumab emtansine treatment; symptomatic cardiac dysfunction; and asymptomatic decline in left ventricular ejection fraction (LVEF). An asymptomatic LVEF decline was defined as a LVEF < 50% and a maximum decrease ≥ 10% from Baseline. The percentage of participants who died is reported.

Secondary Outcome Measures

1. Percentage of Participants Who Experienced at Least 1 Adverse Event During Concurrent Radiotherapy With Trastuzumab Emtansine Treatment [From the start to the end of concurrent radiotherapy (up to 51 weeks)]

2. Percentage of Participants Who Experienced at Least 1 Adverse Event During Concurrent Hormonal Therapy With Trastuzumab Emtansine Treatment [From the start to the end of concurrent hormonal therapy (up to 51 weeks)]

3. Percentage of Participants Who Completed the Planned Duration of Trastuzumab Emtansine Treatment [From the start to the end of trastuzumab emtansine treatment (up to 51 weeks)]

   Participants were to receive up to a total of 17 cycles of trastuzumab emtansine. If trastuzumab was given concurrently with either the optional docetaxel or optional radiation, then the number of 3-week cycles of trastuzumab therapy was subtracted from the planned 17 cycles of trastuzumab emtansine therapy.

4. Percentage of Participants Who Completed ≥ 95% of the Planned Radiotherapy Treatment With Concurrent Trastuzumab Emtansine Administration Without Significant (> 5 Days) Delay [From the start to the end of radiotherapy treatment (up to 51 weeks)]

5. Percentage of Participants With a Pathological Complete Response [Day of surgery]

   Pathological complete response was defined as the absence of invasive neoplastic cells at microscopic examination of the primary tumor and lymph nodes after surgery following primary systemic therapy. Pathological complete response was evaluated in participants treated with neoadjuvant therapy doxorubicin/cyclophosphamide-5-fluorouracil/epirubicin/cyclophosphamide followed by 1 or more doses of trastuzumab emtansine and who underwent surgery.

6. Disease-free Survival at Month 12 [From the start of trastuzumab emtansine for adjuvant patients and from the date of surgery for neoadjuvant patients to 12 months later]

   Disease-free survival was defined as the time from date of first protocol treatment for adjuvant patients or date of surgery for neoadjuvant patients to disease recurrence, occurrence of invasive contralateral breast cancer, other second primary cancer (excluding non-breast second primary), or death, whichever occurred first.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adult patients ≥ 18 years of age.

• Locally advanced, inflammatory, or early stage, unilateral, and histologically confirmed invasive breast cancer documented at a local laboratory (patients with inflammatory breast cancer must be able to have a core needle biopsy).

• Herceptin (HER)2-positive tumor, confirmed by central testing using immunohistochemistry (IHC) and in situ hybridization (ISH) methods.

• Willingness to receive anthracycline-based chemotherapy or have received doxorubicin/cyclophosphamide (AC) OR 5-fluorouracil (FU)/epirubicin/ cyclophosphamide (FEC) in a similar dose and schedule as described in the protocol as part of neoadjuvant or adjuvant treatment.

• For women of childbearing potential and men with partners of childbearing potential, agreement to use a highly effective, non-hormonal form of contraception or 2 effective forms of non-hormonal contraception by the patient and/or partner. Contraception use must continue for the duration of study treatment and for at least 6 months after the last dose of study treatment. Male patients should use condoms for the duration of the study. Specific country requirements will be followed.

• Negative results of serum pregnancy test for premenopausal women of reproductive capacity and for women < 12 months after menopause.

• Patients may enroll before or after AC/FEC chemotherapy has completed.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• Adequate hematologic, biochemistry, and cardiac assessments.

Exclusion Criteria:

• Stage IV breast cancer or bilateral breast cancer.

• Pregnant or breastfeeding women.

• History of other malignancy within the previous 5 years, except contralateral breast cancer and ductal carcinoma in situ (DCIS)/lobular carcinoma in situ (LCIS), appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other cancers with outcome similar to those mentioned above.

• Radiation therapy, immunotherapy, or biotherapy within 5 years before study enrollment; non-cardiotoxic chemotherapy for malignancy treated > 5 years before study enrollment is allowed. Patients receiving AC/FEC in a similar fashion to the study treatment prescribed for adjuvant or neoadjuvant treatment of breast cancer will be allowed to enroll in the study after the completion of their AC/FEC. No other prior history of cardiotoxic chemotherapy is allowed.

• Active cardiac history.

• Current chronic daily treatment with oral corticosteroids or equivalent.

• Patients with severe dyspnea at rest or requiring supplementary oxygen therapy.

• Active, unresolved infections at screening.

• Human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection.

• Major surgery within 4 weeks before enrollment that is unrelated to the breast cancer.

• Patients for whom concomitant radiotherapy + T-DM1 may be contraindicated yet radiation therapy is planned.

• Known hypersensitivity to any of the study drugs or derivatives, including murine proteins.

• Grade ≥ 2 peripheral neuropathy at Baseline.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Fort Myers	Florida	United States	33916
2		Lafayette	Indiana	United States	47905
3		Scarborough	Maine	United States	04074
4		Kensignton	Maryland	United States	20895
5		Boston	Massachusetts	United States	02115
6		Boston	Massachusetts	United States	02130
7		Springfield	Missouri	United States	65804
8		Omaha	Nebraska	United States	68114
9		Lake Success	New York	United States	11042
10		Durham	North Carolina	United States	27710
11		Winston-Salem	North Carolina	United States	27103
12		Sioux Falls	South Dakota	United States	57105
13		Nashville	Tennessee	United States	37203
14		San Antonio	Texas	United States	78258
15		Tacoma	Washington	United States	98405
16		Bruxelles		Belgium	1000
17		Wilrijk		Belgium	2610
18		Besancon		France	25030
19		Montpellier		France	34298
20		Saint Herblain		France	44805
21		Bielefeld		Germany	33604
22		Frankfurt am Main		Germany	60389
23		Hamburg		Germany	20357
24		Köln		Germany	50931
25		Mönchengladbach		Germany	41061
26		Rostock		Germany	18059
27		Bologna	Emilia-Romagna	Italy	40138
28		Lecco	Lombardia	Italy	23900
29		Milano	Lombardia	Italy	20133
30		Candiolo	Piemonte	Italy	10060
31		San Giovanni Rotondo	Puglia	Italy	71013
32		Perugia	Umbria	Italy	06132
33		Vicenza	Veneto	Italy	36100
34		Seoul		Korea, Republic of	110-744
35		Seoul		Korea, Republic of	135-710
36		Seoul		Korea, Republic of	138-736
37		Moscow		Russian Federation	143423
38		Saint-Petersburg		Russian Federation	197758
39		Tula		Russian Federation	300053
40		Barcelona		Spain	08035
41		Jaen		Spain	23007
42		Lerida		Spain	25198
43		Madrid		Spain	28041
44		Madrid		Spain	28046

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT01196052
• Other Study ID Numbers: BO22857; TDM4874g
• First Posted: Sep 8, 2010
• Last Update Posted: Oct 6, 2014
• Last Verified: Sep 1, 2014

• Additional relevant MeSH terms: Breast Neoplasms; Trastuzumab; Ado-Trastuzumab Emtansine; Maytansine

Study Results

Participant Flow

Arm/Group Title	Trastuzumab Emtansine
Arm/Group Description	Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
Period Title: Overall Study
STARTED	153
Received Trastuzumab Emtansine	148
COMPLETED	130
NOT COMPLETED	23

Baseline Characteristics

Arm/Group Title	Trastuzumab Emtansine
Arm/Group Description	Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
Overall Participants	153
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51.1 (11.23)
Sex: Female, Male (Count of Participants)
Female	153 100%
Male	0 0%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With a Cardiac Event Within 12 Weeks After the Start of Trastuzumab Emtansine Treatment
Description	A cardiac event was defined as death from a cardiac cause or severe congestive failure (New York Heart Association [NYHA] Class III or IV) with a decrease in left ventricular ejection fraction (LVEF) of ≥ 10% from Baseline to an LVEF of < 50%.
Time Frame	Baseline to 12 weeks after the start of trastuzumab emtansine treatment

Outcome Measure Data

Analysis Population Description

Cardiac-safety evaluable population: All participants who received at least 1 dose of T-DM1 and met either of the following 2 criteria: (1) Had an echocardiogram/multiple-gated acquisition assessment by 12 weeks after the first dose of T-DM1 or (2) discontinued study treatment because of cardiac toxicity prior to completion of 4 cycles of T-DM1.

Arm/Group Title	Trastuzumab Emtansine
Arm/Group Description	Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
Measure Participants	143
Number (95% Confidence Interval) [Percentage of participants]	0 0%

2. Primary Outcome

Title	Adverse Events, LVEF Function, and Deaths
Description	The following percentages of participants are reported: At least 1 adverse event while receiving T-DM1; at least 1 serious adverse event while receiving T-DM1; an adverse event leading to discontinuation, dose delay, or dose reduction of trastuzumab emtansine treatment; symptomatic cardiac dysfunction; and asymptomatic decline in left ventricular ejection fraction (LVEF). An asymptomatic LVEF decline was defined as a LVEF < 50% and a maximum decrease ≥ 10% from Baseline. The percentage of participants who died is reported.
Time Frame	From the start to the end of trastuzumab emtansine treatment (up to 51 weeks)

Outcome Measure Data

Analysis Population Description

Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine.

Arm/Group Title	Trastuzumab Emtansine
Arm/Group Description	Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
Measure Participants	148
At least 1 adverse event (AE)	98.6 64.4%
At least 1 serious adverse event	10.1 6.6%
An AE leading to treatment discontinuation	13.5 8.8%
An AE leading to dose delay	29.1 19%
An AE leading to dose reduction	21.6 14.1%
Symptomatic cardiac dysfunction	0.0 0%
An asymptomatic decline in LVEF	2.7 1.8%
Deaths	0 0%

3. Secondary Outcome

Title	Percentage of Participants Who Experienced at Least 1 Adverse Event During Concurrent Radiotherapy With Trastuzumab Emtansine Treatment
Time Frame	From the start to the end of concurrent radiotherapy (up to 51 weeks)

Outcome Measure Data

Analysis Population Description

Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. Only participants who received concurrent radiotherapy were included in the analysis.

Arm/Group Title	Trastuzumab Emtansine
Arm/Group Description	Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
Measure Participants	39
Number [Percentage of participants]	94.9 62%

4. Secondary Outcome

Title	Percentage of Participants Who Experienced at Least 1 Adverse Event During Concurrent Hormonal Therapy With Trastuzumab Emtansine Treatment
Time Frame	From the start to the end of concurrent hormonal therapy (up to 51 weeks)

Outcome Measure Data

Analysis Population Description

Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. Only participants who received concurrent hormonal therapy were included in the analysis.

Arm/Group Title	Trastuzumab Emtansine
Arm/Group Description	Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
Measure Participants	62
Number [Percentage of participants]	69.4 45.4%

5. Secondary Outcome

Title	Percentage of Participants Who Completed the Planned Duration of Trastuzumab Emtansine Treatment
Description	Participants were to receive up to a total of 17 cycles of trastuzumab emtansine. If trastuzumab was given concurrently with either the optional docetaxel or optional radiation, then the number of 3-week cycles of trastuzumab therapy was subtracted from the planned 17 cycles of trastuzumab emtansine therapy.
Time Frame	From the start to the end of trastuzumab emtansine treatment (up to 51 weeks)

Outcome Measure Data

Analysis Population Description

Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine.

Arm/Group Title	Trastuzumab Emtansine
Arm/Group Description	Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
Measure Participants	148
Number [Percentage of participants]	82.4 53.9%

6. Secondary Outcome

Title	Percentage of Participants Who Completed ≥ 95% of the Planned Radiotherapy Treatment With Concurrent Trastuzumab Emtansine Administration Without Significant (> 5 Days) Delay
Time Frame	From the start to the end of radiotherapy treatment (up to 51 weeks)

Outcome Measure Data

Analysis Population Description

Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. Only participants who received concurrent radiotherapy and who had radiotherapy dose information reported were included in the analysis.

Arm/Group Title	Trastuzumab Emtansine
Arm/Group Description	Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
Measure Participants	38
Number [Percentage of participants]	94.7 61.9%

7. Secondary Outcome

Title	Percentage of Participants With a Pathological Complete Response
Description	Pathological complete response was defined as the absence of invasive neoplastic cells at microscopic examination of the primary tumor and lymph nodes after surgery following primary systemic therapy. Pathological complete response was evaluated in participants treated with neoadjuvant therapy doxorubicin/cyclophosphamide-5-fluorouracil/epirubicin/cyclophosphamide followed by 1 or more doses of trastuzumab emtansine and who underwent surgery.
Time Frame	Day of surgery

Outcome Measure Data

Analysis Population Description

Efficacy analysis population: All participants who enrolled in the neoadjuvant setting and received surgery, after completing 4 cycles of trastuzumab emtansine treatment.

Arm/Group Title	Trastuzumab Emtansine
Arm/Group Description	Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
Measure Participants	50
Number (95% Confidence Interval) [Percentage of participants]	56.0 36.6%

8. Secondary Outcome

Title	Disease-free Survival at Month 12
Description	Disease-free survival was defined as the time from date of first protocol treatment for adjuvant patients or date of surgery for neoadjuvant patients to disease recurrence, occurrence of invasive contralateral breast cancer, other second primary cancer (excluding non-breast second primary), or death, whichever occurred first.
Time Frame	From the start of trastuzumab emtansine for adjuvant patients and from the date of surgery for neoadjuvant patients to 12 months later

Outcome Measure Data

Analysis Population Description

Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. Due to too few events, the analysis of disease-free survival was not performed.

Arm/Group Title	Trastuzumab Emtansine
Arm/Group Description	Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
Measure Participants	0

Adverse Events

Adverse Event Reporting Description	Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. All adverse events that occurred while participants were receiving trastuzumab emtansine are reported.
Arm/Group Title	Trastuzumab Emtansine
Arm/Group Description	Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
All Cause Mortality
	Trastuzumab Emtansine
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Trastuzumab Emtansine
	Affected / at Risk (%)	# Events
Total	15/148 (10.1%)
Blood and lymphatic system disorders
Febrile neutropenia	1/148 (0.7%)	1
Cardiac disorders
Atrial fibrillation	2/148 (1.4%)	2
Gastrointestinal disorders
Abdominal pain	1/148 (0.7%)	1
Diarrhoea	1/148 (0.7%)	1
General disorders
Pyrexia	2/148 (1.4%)	2
Infections and infestations
Cellulitis	1/148 (0.7%)	1
Device related infection	2/148 (1.4%)	2
Gastroenteritis viral	1/148 (0.7%)	1
Gastrointestinal infection	1/148 (0.7%)	1
Upper respiratory tract infection	1/148 (0.7%)	1
Injury, poisoning and procedural complications
Infusion related reaction	1/148 (0.7%)	1
Radiation pneumonitis	1/148 (0.7%)	1
Investigations
Troponin increased	1/148 (0.7%)	1
Respiratory, thoracic and mediastinal disorders
Epistaxis	1/148 (0.7%)	1
Other (Not Including Serious) Adverse Events
	Trastuzumab Emtansine
	Affected / at Risk (%)	# Events
Total	146/148 (98.6%)
Blood and lymphatic system disorders
Neutropenia	15/148 (10.1%)
Thrombocytopenia	32/148 (21.6%)
Anaemia	13/148 (8.8%)
Ear and labyrinth disorders
Vertigo	8/148 (5.4%)
Eye disorders
Conjunctivitis	9/148 (6.1%)
Dry Eye	8/148 (5.4%)
Gastrointestinal disorders
Nausea	56/148 (37.8%)
Constipation	16/148 (10.8%)
Diarrhoea	21/148 (14.2%)
Vomiting	25/148 (16.9%)
Dry Mouth	20/148 (13.5%)
Stomatitis	9/148 (6.1%)
Abdominal Pain Upper	16/148 (10.8%)
Dyspepsia	12/148 (8.1%)
Abdominal Pain	14/148 (9.5%)
Gastrooesophageal Reflux Disease	8/148 (5.4%)
Gingival Bleeding	12/148 (8.1%)
General disorders
Asthenia	45/148 (30.4%)
Fatigue	34/148 (23%)
Pyrexia	39/148 (26.4%)
Mucosal Inflammation	10/148 (6.8%)
Influenza Like Illness	20/148 (13.5%)
Chills	19/148 (12.8%)
Oedema Peripheral	9/148 (6.1%)
Infections and infestations
Nasopharyngitis	20/148 (13.5%)
Upper Respiratory Tract Infection	15/148 (10.1%)
Urinary Tract Infection	9/148 (6.1%)
Sinusitis	8/148 (5.4%)
Injury, poisoning and procedural complications
Radiation Skin Injury	12/148 (8.1%)
Investigations
Aspartate Aminotransferase Increased	19/148 (12.8%)
Alanine Aminotransferase Increased	18/148 (12.2%)
Metabolism and nutrition disorders
Decreased Appetite	18/148 (12.2%)
Hypokalaemia	9/148 (6.1%)
Musculoskeletal and connective tissue disorders
Myalgia	31/148 (20.9%)
Arthralgia	33/148 (22.3%)
Musculoskeletal Pain	17/148 (11.5%)
Back Pain	16/148 (10.8%)
Muscle Spasms	16/148 (10.8%)
Pain In Extremity	9/148 (6.1%)
Nervous system disorders
Headache	55/148 (37.2%)
Dysgeusia	13/148 (8.8%)
Neuropathy Peripheral	18/148 (12.2%)
Peripheral Sensory Neuropathy	14/148 (9.5%)
Paraesthesia	10/148 (6.8%)
Dizziness	8/148 (5.4%)
Psychiatric disorders
Insomnia	12/148 (8.1%)
Anxiety	9/148 (6.1%)
Depression	11/148 (7.4%)
Reproductive system and breast disorders
Breast Pain	10/148 (6.8%)
Respiratory, thoracic and mediastinal disorders
Epistaxis	47/148 (31.8%)
Cough	18/148 (12.2%)
Dyspnoea	10/148 (6.8%)
Oropharyngeal Pain	9/148 (6.1%)
Skin and subcutaneous tissue disorders
Alopecia	9/148 (6.1%)
Erythema	17/148 (11.5%)
Rash	24/148 (16.2%)
Pruritus	11/148 (7.4%)
Dry Skin	9/148 (6.1%)
Nail Disorder	9/148 (6.1%)
Vascular disorders
Hot Flush	20/148 (13.5%)
Hypertension	8/148 (5.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.