Clinical trials of HER2 inhibitors - TrialResults-center.org

pathology

treatment

patient

Demonstrated benefit and harm

advanced breast cancer (metastatic)

pertuzumab

not classified

versus anti-HER2 antibody + taxanes

No demonstrated result for efficacy

2 trials

meta-analysis

Trial

control

p<0.05

harm

CLEOPATRA, 2012

pertuzumab + trastuzumab +docetaxel vs trastuzumab + docetaxel

OS 0.68 [0.56; 0.83]

PFS 0.62 [0.51; 0.75]

neoSphere (Group B), 2012

pertuzumab + trastuzumab +docetaxel vs trastuzumab + docetaxel

Trial

Treatments

Patients

Method

CLEOPATRA, 2012

pertuzumab plus trastuzumab plus docetaxel (n=406)

vs.

placebo plus trastuzumab plus docetaxel (n=402)

patients with HER2-positive metastatic breast cancer

double-blind

Parallel groups

Sample size: 406/402

Primary endpoint: progression-free survival

FU duration:

neoSphere (Group B), 2012

pertuzumab and trastuzumab plus docetaxel (n=107)

vs.

trastuzumab plus docetaxel (n=107)

4 arms: A) trastuzumab plus docetaxel; B) pertuzumab and trastuzumab plus docetaxel C)pertuzumab and trastuzumab D) pertuzumab plus docetaxel

women with locally advanced, inflammatory, or early HER2-positive breast cancer

Sample size: 107/107

Primary endpoint:

FU duration:

advanced breast cancer (metastatic)

trastuzumab

not classified

versus

No demonstrated result for efficacy

5 trials

meta-analysis

Trial	control	p<0.05	harm	NS
Blackwell, 2010	trastuzumab + lapatinib vs lapatinib alone
Gasparini, 2006	trastuzumab + paclitaxel vs paclitaxel alone
Marty, 2005	trastuzumab + docetaxel vs docetaxel alone
Slamon, 2001	trastuzumab + standard chemotherapy vs standard chemotherapy alone
von Minckwitz, 2009	trastuzumab + capecitabine vs capecitabine alone

Trial	Treatments	Patients	Method
Blackwell, 2010	lapatinib + trastuzumab (n=-9) vs. lapatinib alone (n=-9)	women with ErbB2-positive, trastuzumab-refractory metastatic breast cancer	Sample size: -9/-9 Primary endpoint: progression-free survival FU duration:
Gasparini, 2006	trastuzumab + weekly paclitaxel (n=-9) vs. weekly paclitaxel (n=-9)	patients with advanced breast cancer overexpressing HER-2.	Sample size: -9/-9 Primary endpoint: FU duration:
Marty, 2005	(n=-9) vs. (n=-9)	patients with human epidermal growth factor receptor 2-positive metastatic breast cancer administered as first-line treatment	Sample size: -9/-9 Primary endpoint: FU duration:
Slamon, 2001	standard chemotherapy plus trastuzumab (n=-9) vs. standard chemotherapy alone (n=-9)	women with metastatic breast cancer that overexpressed HER2	Sample size: -9/-9 Primary endpoint: FU duration:
von Minckwitz, 2009	trastuzumab + capecitabine (n=-9) vs. capecitabine alone (n=-9)	Patients with HER-2-positive breast cancer that progresses during treatment with trastuzumab	Sample size: -9/-9 Primary endpoint: FU duration:

advanced breast cancer (metastatic)

trastuzumab

not classified

versus endocrine therapy alone

No demonstrated result for efficacy

2 trials

meta-analysis

Trial	control	p<0.05	harm	NS
Huober, 2012	trastuzumab + letrozole vs letrozole alone
TAnDEM (Kaufman), 2009	trastuzumab + anastrozole vs anastrozole alone

Trial

Treatments

Patients

Method

Huober, 2012

letrozole plus trastuzumab (n=-9)

vs.

letrozole alone (n=-9)

patients with HER2-positive, hormone-receptor-positive metastatic breast cancer

Sample size: -9/-9

Primary endpoint:

FU duration:

TAnDEM (Kaufman), 2009

anastrozole (1 mg/d orally) with trastuzumab (4 mg/kg intravenous infusion on day 1, then 2 mg/kg every week) until progression (n=-9)

vs.

anastrozole (n=-9)

postmenopausal women with human epidermal growth factor receptor 2-positive, hormone receptor-positive metastatic breast cancer

Sample size: -9/-9

Primary endpoint:

FU duration:

advanced breast cancer (metastatic)

trastuzumab emtansine

not classified

versus

No demonstrated result for efficacy

1 trial

meta-analysis

Trial

control

p<0.05

harm

EMILIA, 2012

trastuzumab emtansine vs lapatinib plus capecitabine

OS 0.68 [0.55; 0.85]

PFS 0.65 [0.55; 0.77]

Trial

Treatments

Patients

Method

EMILIA, 2012

Trastuzumab emtansine (n=496)

vs.

lapatinib plus capecitabine (n=495)

patients with HER2-positive advanced breast cancer, who had previously been treated with trastuzumab and a taxane

Parallel groups

Sample size: 496/495

Primary endpoint:

FU duration:

advanced breast cancer (metastatic)

trastuzumab emtansine

not classified

versus placebo or control

No demonstrated result for efficacy

1 trial

meta-analysis

Trial	control	p<0.05	harm	NS
TH3RESA, 2014	trastuzumab emtansine vs usual care	PFS 0.53 [0.42; 0.66]

Trial

Treatments

Patients

Method

TH3RESA, 2014

trastuzumab emtansine (n=404)

vs.

physician's choice (n=198)

patients with progressive HER2-positive advanced breast cancer who had received two or more HER2-directed regimens in the advanced setting

open-label

Parallel groups

Sample size: 404/198

Primary endpoint: progression-free survival (PFS) and overall survival

FU duration:

early breast cancer

pertuzumab

not classified

versus

No demonstrated result for efficacy

1 trial

meta-analysis

Trial	control	p<0.05	harm	NS
	T1 vs T0

Trial

Treatments

Patients

Method

Aphinity

(n=4805)

vs.

(n=0)

people with operable HER2-positive eBC

double-blind

Parallel groups

Sample size: 4805/0

Primary endpoint: iDFS

FU duration:

early breast cancer

trastuzumab

not classified

versus

No demonstrated result for efficacy

11 trials

meta-analysis

Trial	control	p<0.05	harm	NS
	T1 vs T0
	T1 vs T0
	T1 vs T0
	T1 vs T0
	T1 vs T0
	T1 vs T0
	T1 vs T0
	T1 vs T0
	T1 vs T0
	T1 vs T0
	T1 vs T0

Trial	Treatments	Patients	Method
NSABP B31, 2005	52 weeks of trastuzumab (n=-9) vs. no trastuzumab (n=-9)	patients with node-positive, HER2-positive breast cancer	Parallel groups Sample size: -9/-9 Primary endpoint: FU duration:
BCIRG006, 2013	(n=-9) vs. (n=-9)		Sample size: -9/-9 Primary endpoint: FU duration:
Buzdar, 2005	simultaneous weekly trastuzumab for 24 weeks (n=-9) vs. no trastuzumab (n=-9)	patienst with HER 2-positive operable breast cancer	Parallel groups Sample size: -9/-9 Primary endpoint: FU duration:
FinHer, 2006	concomitant treatment with trastuzumab (n=-9) vs. no trastuzumab (n=-9)	Women with tumors that overexpressed HER2/neu	Parallel groups Sample size: -9/-9 Primary endpoint: FU duration:
HERA, 2005	??? (n=-9) vs. ??? (n=-9)	patients with HER2-positive and either node-negative or node-positive breast cancer who had completed locoregional therapy and at least four cycles of neoadjuvant or adjuvant chemotherapy	Sample size: -9/-9 Primary endpoint: FU duration:
N9831, 2005	(n=-9) vs. (n=-9)		Sample size: -9/-9 Primary endpoint: FU duration:
NOAH, 2010	1 year of treatment with trastuzumab (given as neoadjuvant and adjuvant treatment (n=-9) vs. no trastuzumab (n=-9)	patients with HER2-positive locally advanced breast cancer	Sample size: -9/-9 Primary endpoint: FU duration:
PACS-04, 2009	(n=-9) vs. (n=-9)		Sample size: -9/-9 Primary endpoint: FU duration:
N9831 (1)	(n=-9) vs. (n=-9)		Sample size: -9/-9 Primary endpoint: FU duration:
N9831 (2)	(n=-9) vs. (n=-9)		Sample size: -9/-9 Primary endpoint: FU duration:
FinHer (1)	(n=-9) vs. (n=-9)		Sample size: -9/-9 Primary endpoint: FU duration:

HER2 inhibitors Description Results NMA

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HER2 inhibitors
Description Results NMA