History of Changes for Study: NCT00950300

A Study to Compare Subcutaneous (SC) Versus Intravenous (IV) Administered Herceptin (Trastuzumab) in Women With HER2-Positive Early Breast Cancer

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Study Record Versions

Version	Submitted Date	Changes
1	July 30, 2009	None (earliest Version on record)
2	July 31, 2009	Arms and Interventions, Study Identification and Study Status
3	August 18, 2009	Study Status and Contacts/Locations
4	September 14, 2009	Study Status
5	October 15, 2009	Recruitment Status, Contacts/Locations, Study Status, Study Identification and Sponsor/Collaborators
6	November 16, 2009	Contacts/Locations, Study Status and Study Identification
7	December 16, 2009	Study Status and Contacts/Locations
8	January 21, 2010	Contacts/Locations and Study Status
9	February 15, 2010	Contacts/Locations, Arms and Interventions, Study Status and Study Design
10	February 26, 2010	Contacts/Locations, Study Design and Study Status
11	March 25, 2010	Contacts/Locations and Study Status
12	April 15, 2010	Contacts/Locations and Study Status
13	May 25, 2010	Contacts/Locations and Study Status
14	June 2, 2010	Study Status and Study Identification
15	June 15, 2010	Contacts/Locations and Study Status
16	July 15, 2010	Contacts/Locations and Study Status
17	August 16, 2010	Contacts/Locations and Study Status
18	September 23, 2010	Contacts/Locations and Study Status
19	October 15, 2010	Contacts/Locations and Study Status
20	November 19, 2010	Contacts/Locations and Study Status
21	January 18, 2011	Contacts/Locations and Study Status
22	February 2, 2011	Recruitment Status, Study Status and Contacts/Locations
23	February 15, 2011	Contacts/Locations and Study Status
24	July 4, 2011	Contacts/Locations, Study Status and Study Design
25	July 19, 2011	Contacts/Locations, Study Design and Study Status
26	September 19, 2011	Contacts/Locations, Study Status and Study Design
27	October 14, 2011	Contacts/Locations and Study Status
28	November 15, 2011	Contacts/Locations, Study Status and Study Design
29	December 5, 2011	Study Status and Contacts/Locations
30	January 17, 2012	Study Status
31	February 15, 2012	Study Status and Contacts/Locations
32	March 16, 2012	Contacts/Locations and Study Status
33	April 18, 2012	Study Status and Contacts/Locations
34	May 21, 2012	Contacts/Locations and Study Status
35	July 5, 2012	Sponsor/Collaborators, Contacts/Locations and Study Status
36	July 17, 2012	Contacts/Locations and Study Status
37	August 15, 2012	Contacts/Locations and Study Status
38	September 5, 2012	Study Status and Contacts/Locations
39	September 19, 2012	Contacts/Locations and Study Status
40	October 10, 2012	Study Status
41	November 1, 2012	Contacts/Locations and Study Status
42	November 15, 2012	Study Status and Study Identification
43	December 3, 2012	Contacts/Locations and Study Status
44	January 15, 2013	Contacts/Locations, Outcome Measures, Study Status, Study Description and Study Identification
45	February 4, 2013	Study Status
46	February 19, 2013	Contacts/Locations and Study Status
47	February 25, 2013	Study Status
48	March 4, 2013	Contacts/Locations and Study Status
49	March 11, 2013	Contacts/Locations and Study Status
50	March 18, 2013	Contacts/Locations and Study Status
51	March 25, 2013	Contacts/Locations and Study Status
52	April 1, 2013	Contacts/Locations and Study Status
53	April 8, 2013	Contacts/Locations and Study Status
54	April 15, 2013	Study Status
55	April 29, 2013	Contacts/Locations and Study Status
56	May 7, 2013	Study Status
57	May 23, 2013	Contacts/Locations and Study Status
58	May 30, 2013	Study Status
59	June 3, 2013	Study Status
60	July 1, 2013	Study Status
61	July 9, 2013	Study Status
62	July 16, 2013	Study Status
63	July 29, 2013	Study Status
64	August 5, 2013	Study Status
65	August 26, 2013	Study Status
66	September 4, 2013	Study Status
67	September 9, 2013	Study Status
68	October 7, 2013	Study Status
69	October 17, 2013	Study Status
70	October 21, 2013	Contacts/Locations and Study Status
71	October 28, 2013	Contacts/Locations and Study Status
72	November 4, 2013	Study Status and Contacts/Locations
73	November 13, 2013	Study Status
74	November 18, 2013	Study Status
75	November 25, 2013	Study Status
76	December 3, 2013	Study Status and Contacts/Locations
77	December 9, 2013	Study Status
78	December 17, 2013	Study Status
79	January 6, 2014	Study Status
80	January 20, 2014	Contacts/Locations and Study Status
81	February 3, 2014	Study Status
82	February 10, 2014	Study Status
83	February 17, 2014	Study Status
84	February 24, 2014	Study Status
85	March 3, 2014	Study Status
86	March 24, 2014	Study Status
87	April 7, 2014	Study Status
88	May 5, 2014	Study Status
89	May 12, 2014	Study Status
90	May 26, 2014	Study Status
91	June 23, 2014	Study Status and Study Description
92	July 7, 2014	Study Status
93	July 14, 2014	Study Status
94	August 4, 2014	Study Status
95	August 19, 2014	Contacts/Locations and Study Status
96	August 26, 2014	Study Status
97	September 22, 2014	Study Status
98	October 6, 2014	Study Status
99	October 13, 2014	Contacts/Locations and Study Status
100	October 20, 2014	Contacts/Locations and Study Status
101	November 3, 2014	Contacts/Locations and Study Status
102	November 24, 2014	Contacts/Locations and Study Status
103	December 1, 2014	Study Status
104	December 8, 2014	Contacts/Locations and Study Status
105	December 15, 2014	Contacts/Locations and Study Status
106	December 23, 2014	Contacts/Locations and Study Status
107	January 6, 2015	Study Status
108	January 12, 2015	Contacts/Locations, Study Description and Study Status
109	January 19, 2015	Contacts/Locations, Study Description and Study Status
110	February 5, 2015	Study Status, Contacts/Locations and Study Description
111	March 2, 2015	Study Status
112	March 16, 2015	Study Status
113	April 2, 2015	Study Status
114	May 5, 2015	Study Status
115	May 11, 2015	Study Status
116	June 1, 2015	Study Status
117	July 1, 2015	Study Status
118	July 31, 2015	Study Status
119	August 17, 2015	Study Status
120	September 1, 2015	Study Status
121	October 1, 2015	Study Status
122	November 2, 2015	Contacts/Locations and Study Status
123	December 1, 2015	Study Status and Contacts/Locations
124	December 31, 2015	Study Status
125	February 1, 2016	Arms and Interventions, Outcome Measures, Study Status, Study Identification, Eligibility and Study Description
126	March 1, 2016	Study Status
127	November 22, 2016	Study Status, Outcome Measures, Arms and Interventions, Study Identification, Results and Eligibility
128	February 9, 2017	Recruitment Status, Contacts/Locations, Study Status, Outcome Measures and Baseline Characteristics
129	August 11, 2017	Study Status and Contacts/Locations
130	October 30, 2017	Contacts/Locations and Study Status
131	December 21, 2017	Adverse Events, Outcome Measures, Participant Flow, Contacts/Locations, Study Status and More Information

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	BO22227
Brief Title:	A Study to Compare Subcutaneous (SC) Versus Intravenous (IV) Administered Herceptin (Trastuzumab) in Women With HER2-Positive Early Breast Cancer
Official Title:	A Randomized Open-label Study to Compare the Pharmacokinetics, Efficacy and Safety of Subcutaneous (SC) Herceptin (Trastuzumab) With Intravenous (IV) Herceptin (Trastuzumab) Administered in Women With HER2-positive Early Breast Cancer
Secondary IDs:	2008-007326-19

Study Status


Record Verification:	July 2009
Overall Status:	Not yet recruiting
Study Start:	July 2009
Primary Completion:
Study Completion:	March 2014 [Anticipated]

First Submitted:	July 30, 2009
First Submitted that Met QC Criteria:	July 30, 2009
First Posted:	July 31, 2009 [Estimate]

Last Update Submitted that Met QC Criteria:	July 30, 2009
Last Update Posted:	July 31, 2009 [Estimate]

Sponsor/Collaborators


Sponsor:	Hoffmann-La Roche
Responsible Party:
Collaborators:

Oversight


U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:

Study Description

Brief Summary:

In this open-label multicenter trial patients with operable or locally advanced breast cancer will be randomized to pre-operative treatment with 8 cycles of chemotherapy (docetaxel followed by 5-fluorouracil/epirubicin/cyclophosphamide) concurrent with either SC Herceptin or IV Herceptin. After surgery patients will receive a further 10 cycles of Herceptin SC or IV as per randomization to complete 1 year of treatment. Patients will be followed for up to 2 years after the end of treatment for safety and efficacy. Target sample size is >500.

Detailed Description:

Conditions


Conditions:	Breast Cancer
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 3
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	None (Open Label)
Allocation:	Randomized
Enrollment:	552 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: 1	Drug: Herceptin (trastuzumab) administered sc, day 1 of each 3-week cycle, 18 cycles Drug: docetaxel 75 mg/sqm iv every 3 weeks, cycles 1 - 4 Drug: 5-fluorouracil 500 mg/sqm iv every 3 weeks, cycles 5 - 8 Drug: epirubicin 75 mg/sqm iv every 3 weeks, cycles 5 - 8 Drug: cyclophosphamide 500 mg/sqm iv every 3 weeks, cycles 5 - 8
Active Comparator: 2	Drug: Herceptin (trastuzumab) administered iv, day 1 of each 3-week cycle, 18 cycles Drug: docetaxel 75 mg/sqm iv every 3 weeks, cycles 1 - 4 Drug: 5-fluorouracil 500 mg/sqm iv every 3 weeks, cycles 5 - 8 Drug: epirubicin 75 mg/sqm iv every 3 weeks, cycles 5 - 8 Drug: cyclophosphamide 500 mg/sqm iv every 3 weeks, cycles 5 - 8

Outcome Measures


Primary Outcome Measures:
1.	trastuzumab serum concentrations, comparing sc versus iv administration [ Time Frame: throughout cycles 1 to 8 ]
2.	pathologic complete response [ Time Frame: after surgery between cycles 8 and 9 ]
Secondary Outcome Measures:
1.	trastuzumab serum concentrations, comparing sc versus iv administration after surgery [ Time Frame: throughout cycles 9 to 13 ]
2.	total pathologic complete response [ Time Frame: after surgery between cycles 8 and 9 ]
3.	overall response rate [ Time Frame: after 2, 4, 6 and 8 cycles of treatment ]
4.	progression and recurrence free survival [ Time Frame: after 2,4,6,8 and 18 cycles of treatment and after 6, 12 and 24 months of follow-up ]
5.	overall survival [ Time Frame: event-driven ]
6.	safety and tolerability [ Time Frame: throughout the study ]
7.	immunogenicity (formation of anti-trastuzumab antibodies) [ Time Frame: sampling at follow-up visits 3, 6, 12, 18 and 24 months after last dose of study drug ]

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	Female
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: Adult women >/= 18 years of age Non-metastatic primary invasive adenocarcinoma of the breast clinical stage I-IIIC, including inflammatory and multicentric breast cancer, tumour size >/= 1 cm, histologically confirmed, HER2-positive At least 1 measurable lesion in breast or lymph nodes according to RECIST v1.0 criteria, except for inflammatory carcinoma Baseline LVEF >/= 55% Exclusion Criteria: History of any prior (ipsi- and/or contralateral) invasive breast carcinoma Past or current history of malignant neoplasms, except for curatively treated basal and squamous cell carcinoma of the skin and in situ carcinoma of the cervix Metastatic disease Any prior therapy with anthracyclines Prior anti-HER2 therapy or biologic or immunotherapy Serious cardiac illness Pregnant or lactating women

Contacts/Locations


Central Contact Person:	Please reference Study ID Number: BO22227 Telephone: 973-235-5000
Central Contact Backup:	or Telephone: 800-526-6367 (FOR US ONLY)
Study Officials:	Clinical Trials Study Director Hoffmann-La Roche
Locations:	Argentina
	Buenos Aires, Argentina, 1617
	Córdoba, Argentina, 5000
	La Pampa, Argentina, 6300
	Tucuman, Argentina, T4000IAK
	Tucuman, Argentina, T400IAK
	Brazil
	Curitiba, Brazil, 80060-150
	Itajaí, Brazil, 88301-220
	JAÚ, Brazil, 17210-080
	Natal, Brazil, 59062-000
	Porto Alegre, Brazil, 91350-200
	Salvador, Brazil, 40170-070
	Sao Paulo, Brazil, 01317-000
	Sorocaba, Brazil, 18030-510
	São Paulo, Brazil, 01246-902
	Canada, Quebec
	Montreal, Quebec, Canada, H1T 2M4
	Quebec City, Quebec, Canada, G1S 4L8
	Colombia
	Bogota, Colombia, 0
	Bogota, Colombia
	Pereira, Colombia
	Costa Rica
	San Jose, Costa Rica, 0
	Czech Republic
	Olomouc, Czech Republic, 775 20
	Pardubice, Czech Republic, 532 03
	Praha, Czech Republic, 140 59
	Praha, Czech Republic, 180 81
	Ecuador
	Cuenca, Ecuador
	Guayaquil, Ecuador
	Quito, Ecuador, 2569
	Quito, Ecuador
	Estonia
	Tallinn, Estonia, 11619
	Tartu, Estonia, 51003
	France
	Besancon, France, 25030
	Grenoble, France, 38028
	Grenoble, France, 38043
	Marseille, France, 13273
	Paris, France, 75010
	Paris, France, 75248
	Saint-cloud, France, 92210
	Germany
	Berlin, Germany, 10117
	Berlin, Germany, 10716
	Bonn, Germany, 53113
	Dortmund, Germany, 44137
	Hannover, Germany, 30177
	Leipzig, Germany, 04277
	Lemgo, Germany, 32657
	Offenbach, Germany, 63069
	Rodewisch, Germany, 08228
	Guatemala
	Guatemala City, Guatemala, 01009
	Hong Kong
	Hong Kong, Hong Kong, 852
	Hungary
	Budapest, Hungary, 1082
	Gyor, Hungary, 9023
	Szeged, Hungary, 6720
	Israel
	Jerusalem, Israel, 91120
	Petach Tikva, Israel, 49100
	Ramat Gan, Israel, 52621
	Tel Aviv, Israel, 64239
	Italy
	Legnano, Italy, 20025
	Napoli, Italy, 80131
	Pavia, Italy, 27100
	Korea, Republic of
	Seoul, Korea, Republic of, 135-170
	Seoul, Korea, Republic of, 136-705
	Seoul, Korea, Republic of, 138-736
	Mexico
	D.f., Mexico, 04980
	Guadalajara, Mexico, 44280
	Obregon, Mexico, 85000
	Sinaloa, Mexico, 80230
	Panama
	Panama, Panama, 0834-02723
	Peru
	Arequipa, Peru
	Lima, Peru, 27
	Lima, Peru, 41
	Poland
	Lublin, Poland, 20-090
	Olsztyn, Poland, 10-513
	Poznan, Poland, 61-878
	Warszawa, Poland, 02-781
	Russian Federation
	Ivanovo, Russian Federation, 153040
	Moscow, Russian Federation, 115478
	Moscow, Russian Federation, 143423
	Pyatigorsk, Russian Federation, 357502
	Ryazan, Russian Federation, 390011
	Samara, Russian Federation, 443066
	Saratov, Russian Federation, 410038
	St Petersburg, Russian Federation, 191104
	St Petersburg, Russian Federation, 197022
	St Petersburg, Russian Federation, 197758
	Stavropol, Russian Federation, 355047
	Tula, Russian Federation, 300040
	Slovakia
	Kosice, Slovakia, 04191
	Poprad, Slovakia, 058 01
	South Africa
	Bloemfontein, South Africa, 9301
	Cape Town, South Africa, 7500
	Johannesburg, South Africa, 2193
	Lynnwood, South Africa, 0081
	Observatory, South Africa, 7935
	Sandton, South Africa, 2199
	Spain
	Madrid, Spain, 28007
	Reus, Spain, 43201
	Santiago de Compostela, Spain, 15706
	Valencia, Spain, 46010
	Zaragoza, Spain, 50009
	Sweden
	Uppsala, Sweden, 75185
	Taiwan
	Taipei, Taiwan, 112
	Thailand
	Bangkok, Thailand, 10400
	Bangkok, Thailand, 10700
	Songkhla, Thailand, 90110
	Turkey
	Ankara, Turkey, 06100
	Antalya, Turkey, 07070
	Istanbul, Turkey, 34390
	Izmir, Turkey, 35340

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