Trial Outcomes & Findings for A Study of Herceptin (Trastuzumab) in Women With Metastatic Breast Cancer (NCT NCT00475670)

Last Updated: 2014-09-15

Results Overview

CR was defined for target lesions (TLs) as the disappearance of all lesions, and for nontarget lesions (NTLs) as the disappearance of all nontarget nonmeasurable lesions. PR was defined for TLs as at least a 30 percent (%) decrease from baseline (BL) in the sum of longest diameter (SLD) of TLs. 95% confidence interval for one-sample binomial using Pearson-Clopper method.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

44 participants

Primary outcome timeframe

Baseline (BL); Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited

Results posted on

2014-09-15

Participant Flow

Participant milestones

Participant milestones
Measure	Trastuzumab Monotherapy Participants received either an initial loading dose of trastuzumab 4 milligrams per kilogram (mg/kg), intravenously (IV), on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.	Trastuzumab, Taxane Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator's discretion) for at least 18 weeks: docetaxel 100 mg/square meter (m\^2), IV, once every 3 weeks, OR, paclitaxel 75 mg/m\^2, IV, once per week, OR, paclitaxel 175 mg/m\^2, IV, once every 3 weeks.
Overall Study STARTED	3	41
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	3	41

Reasons for withdrawal

Reasons for withdrawal
Measure	Trastuzumab Monotherapy Participants received either an initial loading dose of trastuzumab 4 milligrams per kilogram (mg/kg), intravenously (IV), on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.	Trastuzumab, Taxane Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator's discretion) for at least 18 weeks: docetaxel 100 mg/square meter (m\^2), IV, once every 3 weeks, OR, paclitaxel 75 mg/m\^2, IV, once per week, OR, paclitaxel 175 mg/m\^2, IV, once every 3 weeks.
Overall Study Death	0	1
Overall Study Lack of Efficacy	3	34
Overall Study Refused treatment	0	2
Overall Study Failure to Return	0	1
Overall Study Other	0	3

Baseline Characteristics

A Study of Herceptin (Trastuzumab) in Women With Metastatic Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Trastuzumab Monotherapy n=3 Participants Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.	Trastuzumab, Taxane n=41 Participants Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator's discretion) for at least 18 weeks: docetaxel 100 mg/m\^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m\^2, IV, once per week, OR, paclitaxel 175 mg/m\^2, IV, once every 3 weeks.	Total n=44 Participants Total of all reporting groups
Age, Continuous	40 years n=5 Participants	54 years n=7 Participants	54 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	41 Participants n=7 Participants	44 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (BL); Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited

Population: FAS; Cohort A (trastuzumab monotherapy) was closed prematurely due to enrollment difficulties. Therefore, Cohort A included only 3 participants and none of the data from these 3 participants were analyzed for any of the specified endpoints.

Outcome measures

Outcome measures
Measure	Trastuzumab Monotherapy Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.	Trastuzumab, Taxane n=41 Participants Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator's discretion) for at least 18 weeks: docetaxel 100 mg/m\^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m\^2, IV, once per week, OR, paclitaxel 175 mg/m\^2, IV, once every 3 weeks.
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) According to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 Guidelines	—	61.0 percentage of participants Interval 48.7 to 80.4

SECONDARY outcome

Timeframe: BL, Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited

Population: FAS. Duration of response was assessed in participants with a best overall response of CR or PR. Cohort A (trastuzumab monotherapy) was closed prematurely due to enrollment difficulties. Therefore, Cohort A included only 3 participants and none of the data from these 3 participants were analyzed for any of the specified endpoints.

Duration of response was defined as the time from first confirmed CR or PR until death or progressive disease (PD). For TLs, PD was defined as at least a 20% increase in the SLD of the TL, taking as reference the smallest SLD recorded since the beginning of treatment or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of one or more new lesions or unequivocal progression of existing non target non-measurable lesions. Participants were censored at the date of the last tumor assessment.

Outcome measures

Outcome measures
Measure	Trastuzumab Monotherapy Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.	Trastuzumab, Taxane n=25 Participants Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator's discretion) for at least 18 weeks: docetaxel 100 mg/m\^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m\^2, IV, once per week, OR, paclitaxel 175 mg/m\^2, IV, once every 3 weeks.
Duration of Response - Percentage of Participants With Progressive Disease or Death	—	88.0 percentage of participants

SECONDARY outcome

The time, in months, from when the response (CR or PR) was first noted until the date of documented PD, death, or withdrawal, whichever occurred first. Participants were censored at the date of the last tumor assessment.

Outcome measures

Outcome measures
Measure	Trastuzumab Monotherapy Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.	Trastuzumab, Taxane n=25 Participants Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator's discretion) for at least 18 weeks: docetaxel 100 mg/m\^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m\^2, IV, once per week, OR, paclitaxel 175 mg/m\^2, IV, once every 3 weeks.
Duration of Response	—	8.0 months Interval 5.0 to 15.0

SECONDARY outcome

PFS was defined as the time from day of first study drug infusion until death or PD. Participants were censored at the date of the last tumor assessment.

Outcome measures

Outcome measures
Measure	Trastuzumab Monotherapy Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.	Trastuzumab, Taxane n=41 Participants Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator's discretion) for at least 18 weeks: docetaxel 100 mg/m\^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m\^2, IV, once per week, OR, paclitaxel 175 mg/m\^2, IV, once every 3 weeks.
Progression-free Survival (PFS) - Percentage of Participants With Progressive Disease	—	87.8 percentage of participants

SECONDARY outcome

The time, in months, from BL to PFS event.

Outcome measures

Outcome measures
Measure	Trastuzumab Monotherapy Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.	Trastuzumab, Taxane n=41 Participants Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator's discretion) for at least 18 weeks: docetaxel 100 mg/m\^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m\^2, IV, once per week, OR, paclitaxel 175 mg/m\^2, IV, once every 3 weeks.
Progression-Free Survival	—	8.0 months Interval 6.0 to 11.0

SECONDARY outcome

Treatment failure was defined as the time from first study drug infusion to failure. Failure was defined as any of the following: PD, death, withdrawal due to adverse event (AE) or lab abnormality, or refusal of treatment. Participants were censored at the last date recorded in the case report form (CRF) or the date of withdrawal.

Outcome measures

Outcome measures
Measure	Trastuzumab Monotherapy Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.	Trastuzumab, Taxane n=41 Participants Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator's discretion) for at least 18 weeks: docetaxel 100 mg/m\^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m\^2, IV, once per week, OR, paclitaxel 175 mg/m\^2, IV, once every 3 weeks.
Percentage of Participants With Treatment Failure	—	95.1 percentage of participants

SECONDARY outcome

The time, in months, from BL to treatment failure.

Outcome measures

Outcome measures
Measure	Trastuzumab Monotherapy Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.	Trastuzumab, Taxane n=41 Participants Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator's discretion) for at least 18 weeks: docetaxel 100 mg/m\^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m\^2, IV, once per week, OR, paclitaxel 175 mg/m\^2, IV, once every 3 weeks.
Time to Treatment Failure	—	8.0 months Interval 6.0 to 11.0

SECONDARY outcome

Clinical benefit was defined as stable disease (SD) for 6 months or longer, or a confirmed overall response of CR or PR. For TLs, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since the beginning of treatment. For NTLs, SD was synonymous with incomplete response and defined as the persistence of one or more NTLs and/or maintenance of tumor marker level above the normal limits.

Outcome measures

Outcome measures
Measure	Trastuzumab Monotherapy Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.	Trastuzumab, Taxane n=41 Participants Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator's discretion) for at least 18 weeks: docetaxel 100 mg/m\^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m\^2, IV, once per week, OR, paclitaxel 175 mg/m\^2, IV, once every 3 weeks.
Percentage of Participants With Clinical Benefit According to RECIST Guidelines	—	70.7 percentage of participants Interval 54.5 to 83.9

SECONDARY outcome

Timeframe: BL, Day 1 of Weeks 1, 4, 7, 10, 13, 16, 19, 25, 37, and 5 at the last administration of study treatment, every 24 weeks thereafter until disease progression or death, yearly thereafter up to 2 years after cessation of recruitment

OS was defined as the time from the date of enrollment to the date of death due to any cause. Participants were censored at the last date recorded in the CRF.

Outcome measures

Outcome measures
Measure	Trastuzumab Monotherapy Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.	Trastuzumab, Taxane n=41 Participants Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator's discretion) for at least 18 weeks: docetaxel 100 mg/m\^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m\^2, IV, once per week, OR, paclitaxel 175 mg/m\^2, IV, once every 3 weeks.
Overall Survival - Percentage of Participants Who Died	—	63.4 percentage of participants

SECONDARY outcome

Timeframe: BL, Day 1 of Weeks 1, 4, 7, 10, 13, 16, 19, 25, 37, and 52 at the last administration of study treatment, every 24 weeks thereafter until disease progression or death, yearly thereafter up to 2 years after cessation of recruitment

The time, in months, from BL to death due to any cause.

Outcome measures

Outcome measures
Measure	Trastuzumab Monotherapy Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.	Trastuzumab, Taxane n=41 Participants Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator's discretion) for at least 18 weeks: docetaxel 100 mg/m\^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m\^2, IV, once per week, OR, paclitaxel 175 mg/m\^2, IV, once every 3 weeks.
Overall Survival	—	25.0 months Interval 16.0 to 33.0

Adverse Events

Trastuzumab Monotherapy

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Trastuzumab, Taxane

Serious events: 6 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Trastuzumab Monotherapy n=3 participants at risk Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.	Trastuzumab, Taxane n=41 participants at risk Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator's discretion) for at least 18 weeks: docetaxel 100 mg/m\^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m\^2, IV, once per week, OR, paclitaxel 175 mg/m\^2, IV, once every 3 weeks.
Infections and infestations Bacterial Infection	0.00% 0/3 • Adverse events and serious adverse events were recorded from study start to 28 days after the last dose of study drug. Serious adverse events that were related to study medication or were cardiac are reported until 2 years after enrollment. The safety analysis population included all participants who received at least 1 dose of either trastuzumab or taxane.	2.4% 1/41 • Adverse events and serious adverse events were recorded from study start to 28 days after the last dose of study drug. Serious adverse events that were related to study medication or were cardiac are reported until 2 years after enrollment. The safety analysis population included all participants who received at least 1 dose of either trastuzumab or taxane.
Infections and infestations Bronchitis	0.00% 0/3 • Adverse events and serious adverse events were recorded from study start to 28 days after the last dose of study drug. Serious adverse events that were related to study medication or were cardiac are reported until 2 years after enrollment. The safety analysis population included all participants who received at least 1 dose of either trastuzumab or taxane.	2.4% 1/41 • Adverse events and serious adverse events were recorded from study start to 28 days after the last dose of study drug. Serious adverse events that were related to study medication or were cardiac are reported until 2 years after enrollment. The safety analysis population included all participants who received at least 1 dose of either trastuzumab or taxane.
Infections and infestations Sepsis	0.00% 0/3 • Adverse events and serious adverse events were recorded from study start to 28 days after the last dose of study drug. Serious adverse events that were related to study medication or were cardiac are reported until 2 years after enrollment. The safety analysis population included all participants who received at least 1 dose of either trastuzumab or taxane.	2.4% 1/41 • Adverse events and serious adverse events were recorded from study start to 28 days after the last dose of study drug. Serious adverse events that were related to study medication or were cardiac are reported until 2 years after enrollment. The safety analysis population included all participants who received at least 1 dose of either trastuzumab or taxane.
Blood and lymphatic system disorders Febrile Neutropenia	0.00% 0/3 • Adverse events and serious adverse events were recorded from study start to 28 days after the last dose of study drug. Serious adverse events that were related to study medication or were cardiac are reported until 2 years after enrollment. The safety analysis population included all participants who received at least 1 dose of either trastuzumab or taxane.	2.4% 1/41 • Adverse events and serious adverse events were recorded from study start to 28 days after the last dose of study drug. Serious adverse events that were related to study medication or were cardiac are reported until 2 years after enrollment. The safety analysis population included all participants who received at least 1 dose of either trastuzumab or taxane.
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • Adverse events and serious adverse events were recorded from study start to 28 days after the last dose of study drug. Serious adverse events that were related to study medication or were cardiac are reported until 2 years after enrollment. The safety analysis population included all participants who received at least 1 dose of either trastuzumab or taxane.	2.4% 1/41 • Adverse events and serious adverse events were recorded from study start to 28 days after the last dose of study drug. Serious adverse events that were related to study medication or were cardiac are reported until 2 years after enrollment. The safety analysis population included all participants who received at least 1 dose of either trastuzumab or taxane.
General disorders Sudden Death	0.00% 0/3 • Adverse events and serious adverse events were recorded from study start to 28 days after the last dose of study drug. Serious adverse events that were related to study medication or were cardiac are reported until 2 years after enrollment. The safety analysis population included all participants who received at least 1 dose of either trastuzumab or taxane.	2.4% 1/41 • Adverse events and serious adverse events were recorded from study start to 28 days after the last dose of study drug. Serious adverse events that were related to study medication or were cardiac are reported until 2 years after enrollment. The safety analysis population included all participants who received at least 1 dose of either trastuzumab or taxane.
Vascular disorders Lymphoedema	0.00% 0/3 • Adverse events and serious adverse events were recorded from study start to 28 days after the last dose of study drug. Serious adverse events that were related to study medication or were cardiac are reported until 2 years after enrollment. The safety analysis population included all participants who received at least 1 dose of either trastuzumab or taxane.	2.4% 1/41 • Adverse events and serious adverse events were recorded from study start to 28 days after the last dose of study drug. Serious adverse events that were related to study medication or were cardiac are reported until 2 years after enrollment. The safety analysis population included all participants who received at least 1 dose of either trastuzumab or taxane.

Other adverse events

Additional Information

Medical Communications

Hoffman-LaRoche

Phone: 800-821-8590

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER