Paclitaxel With or Without Carboplatin and/or Bevacizumab Followed by Doxorubicin and Cyclophosphamide in Treating Patients With Breast Cancer That Can Be Removed by Surgery

Draft scope assessment: unclear. Attached because the study's own record names HER2. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Assessment of the difference in percentage of participants with pCR in the breast between regimens that contain carboplatin (arms 3\&4) versus not (arms 1\&2) will use a one-sided chi square test. 95% confidence intervals around the incidence of pCR will also be constructed using exact binomial methods.

All patients who began protocol neoadjuvant therapy and are assessable for pCR endpoint (N=433).

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primary · POSTED

Assessment of the difference in percentage of participants with pCR in the breast between regimens that contain bevacizumab (arms 2\&4) versus not (arms 1\&3) will use a one-sided chi square test. 95% confidence intervals around the incidence of pCR will also be constructed using exact binomial methods.

All patients who began protocol neoadjuvant therapy and are assessable for pCR endpoint (N=433).

→

secondary · POSTED

Comparing regimens that contain carboplatin (arms 3\&4) versus not (arms 1\&2).

Source null

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secondary · POSTED

Comparing regimens that contain bevacizumab (arms 2\&4) versus not (arms 1\&3).

Source null

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secondary · POSTED

Stage II is (T2,T3, N0, M0) tumor size more than 2 cm but no deep extradermal structure invasion, no regional lymph node metastasis, and no distant metastasis. Stage III is (T4, N0, M0) tumor invasion of deep extradermal structures, no regional lymph node metasis, and no distant metasasis or (Any T, N1, M0) Any tumor size, regional lymph node metastasis, and no distant metastasis.

Source null

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secondary · POSTED

Assessed by RECIST, each patient will have a pre-therapy baseline radiographic tumor measurement, preferably by MRI, however if logistic or practical or financial issues preclude MRI use, mammogram or ultrasound may be substituted. The longest diameter (LD) of the target lesion at the time of study initiation will be reported as the baseline LD. The baseline LD of the target lesion will be used as reference to further characterize the objective tumor response of the measurable dimension of the disease. Radiographic complete response: Disappearance of the target lesion. Radiographic partial response (PR): At least a 30% decrease in the longest diameter (LD) of the target lesion taking as reference the baseline LD.

Source null

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-breast-cancer-herceptin-hylecta-6ea26642
nct id: NCT00861705
trial label: Paclitaxel With or Without Carboplatin and/or Bevacizumab Followed by Doxorubicin and Cyclophosphamide in Treating Patients With Breast Cancer That Can Be Removed by Surgery
applicability: unclear
applicability note: Attached because the study's own record names HER2. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 6
harms Count: 4
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-6ea26642
nct id
NCT00861705
outcome key
om-0000
source section id
NCT00861705-om-0000
source outcome index
0
endpoint
Pathologic Complete Response (pCR) in the Breast. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is).
endpoint definition
Assessment of the difference in percentage of participants with pCR in the breast between regimens that contain carboplatin (arms 3\&4) versus not (arms 1\&2) will use a one-sided chi square test. 95% confidence intervals around the incidence of pCR will also be constructed using exact binomial methods.
time origin
At the time of definitive surgical removal, up to 28 weeks
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All patients who began protocol neoadjuvant therapy and are assessable for pCR endpoint (N=433).
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-6ea26642
nct id
NCT00861705
outcome key
om-0001
source section id
NCT00861705-om-0001
source outcome index
1
endpoint
Pathologic Complete Response (pCR) in the Breast. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is).
endpoint definition
Assessment of the difference in percentage of participants with pCR in the breast between regimens that contain bevacizumab (arms 2\&4) versus not (arms 1\&3) will use a one-sided chi square test. 95% confidence intervals around the incidence of pCR will also be constructed using exact binomial methods.
time origin
At the time of definitive surgical removal, up to 28 weeks
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All patients who began protocol neoadjuvant therapy and are assessable for pCR endpoint (N=433).
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-6ea26642
nct id
NCT00861705
outcome key
om-0002
source section id
NCT00861705-om-0002
source outcome index
2
endpoint
Pathologic Complete Response (pCR) in the Breast and Axilla. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is) Plus the Absence of Any Tumor Deposit >0.2 mm in Sampled Axillary Nodes (ypT0/isN0).
endpoint definition
Comparing regimens that contain carboplatin (arms 3\&4) versus not (arms 1\&2).
time origin
At the time of definitive surgical removal, up to 28 weeks
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-6ea26642
nct id
NCT00861705
outcome key
om-0003
source section id
NCT00861705-om-0003
source outcome index
3
endpoint
Pathologic Complete Response (pCR) in the Breast and Axilla. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is) Plus the Absence of Any Tumor Deposit >0.2 mm in Sampled Axillary Nodes (ypT0/isN0).
endpoint definition
Comparing regimens that contain bevacizumab (arms 2\&4) versus not (arms 1\&3).
time origin
At the time of definitive surgical removal, up to 28 weeks
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-6ea26642
nct id
NCT00861705
outcome key
om-0004
source section id
NCT00861705-om-0004
source outcome index
4
endpoint
Pathologic Stage in the Breast and in the Breast Plus Axilla as Measured by American Joint Committee on Cancer (AJCC) Tumor Node Metastasis (TNM) Staging Criteria (Version 6)
endpoint definition
Stage II is (T2,T3, N0, M0) tumor size more than 2 cm but no deep extradermal structure invasion, no regional lymph node metastasis, and no distant metastasis. Stage III is (T4, N0, M0) tumor invasion of deep extradermal structures, no regional lymph node metasis, and no distant metasasis or (Any T, N1, M0) Any tumor size, regional lymph node metastasis, and no distant metastasis.
time origin
at definitive surgery, up to 28 weeks
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-6ea26642
nct id
NCT00861705
outcome key
om-0005
source section id
NCT00861705-om-0005
source outcome index
5
endpoint
Radiographic Response Assessed by Tumor Measurement
endpoint definition
Assessed by RECIST, each patient will have a pre-therapy baseline radiographic tumor measurement, preferably by MRI, however if logistic or practical or financial issues preclude MRI use, mammogram or ultrasound may be substituted. The longest diameter (LD) of the target lesion at the time of study initiation will be reported as the baseline LD. The baseline LD of the target lesion will be used as reference to further characterize the objective tumor response of the measurable dimension of the disease. Radiographic complete response: Disappearance of the target lesion. Radiographic partial response (PR): At least a 30% decrease in the longest diameter (LD) of the target lesion taking as reference the baseline LD.
time origin
Baseline; at completion of neoadjuvant therapy
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-6ea26642
nct id
NCT00861705
outcome key
om-0000
arm key
OG000
arm label
Factor A: Carboplatin
regimen
Factor A is the addition or not of carboplatin: the experimental regimens included carboplatin (Arms 3 \& 4).
analyzed count
221
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00861705-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-6ea26642
nct id
NCT00861705
outcome key
om-0000
arm key
OG001
arm label
Factor A: No Carboplatin
regimen
Factor A is the addition or not of carboplatin; the control regimens did not include carboplatin (Arms 1 \& 2).
analyzed count
212
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00861705-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-6ea26642
nct id
NCT00861705
outcome key
om-0001
arm key
OG000
arm label
Factor B: Bevacizumab
regimen
Factor B is the addition or not of bevacizumab: the experimental regimens included bevacizumab (Arms 2 \& 4).
analyzed count
215
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00861705-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-6ea26642
nct id
NCT00861705
outcome key
om-0001
arm key
OG001
arm label
Factor B: No Bevacizumab
regimen
Factor B is the addition or not of bevacizumab: the control regimens did not include bevacizumab (Arms 1 \& 3)
analyzed count
218
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00861705-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-6ea26642
nct id
NCT00861705
outcome key
om-0002
arm key
OG000
arm label
Factor A: Carboplatin
regimen
Factor A is the addition or not of carboplatin: the experimental regimens included carboplatin (Arms 3 \& 4).
analyzed count
221
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00861705-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-6ea26642
nct id
NCT00861705
outcome key
om-0002
arm key
OG001
arm label
Factor A: No Carboplatin
regimen
Factor A is the addition or not of carboplatin; the control regimens did not include carboplatin (Arms 1 \& 2).
analyzed count
212
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00861705-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-6ea26642
nct id
NCT00861705
outcome key
om-0003
arm key
OG000
arm label
Factor B: Bevacizumab
regimen
Factor B is the addition or not of bevacizumab: the experimental regimens included bevacizumab (Arms 2 \& 4).
analyzed count
215
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00861705-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-6ea26642
nct id
NCT00861705
outcome key
om-0003
arm key
OG001
arm label
Factor B: No Bevacizumab
regimen
Factor B is the addition or not of bevacizumab: the control regimens did not include bevacizumab (Arms 1 \& 3)
analyzed count
218
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00861705-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-6ea26642
nct id
NCT00861705
outcome key
om-0004
arm key
OG000
arm label
Arm 1 (Pac --> ddAC)
regimen
Patients receive paclitaxel (pac) IV over 60 minutes once weekly in weeks 1-12. Patients then receive dose-dense doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 5-30 minutes (ddAC) once in weeks 13, 15, 17, and 19. doxorubicin hydrochloride: Given IV paclitaxel: Given IV cyclophosphamide: Given IV
analyzed count
107
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00861705-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-6ea26642
nct id
NCT00861705
outcome key
om-0004
arm key
OG001
arm label
Arm 2 (Pac + Bev --> ddAC + Bev)
regimen
Patients receive pac and ddAC as in arm 1. Patients also receive bevacizumab (bev) IV over 30-90 minutes in weeks 1, 3, 5, 7, 9, 11, 13, 15, and 17. doxorubicin hydrochloride: Given IV paclitaxel: Given IV cyclophosphamide: Given IV bevacizumab: Given IV
analyzed count
105
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00861705-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-6ea26642
nct id
NCT00861705
outcome key
om-0004
arm key
OG002
arm label
Arm 3 (Pac + Carboplatin --> ddAC)
regimen
Patients receive pac and ddAC as in arm 1. Patients also receive carboplatin IV over 30 minutes once in weeks 1, 4, 7, and 10. doxorubicin hydrochloride: Given IV paclitaxel: Given IV cyclophosphamide: Given IV carboplatin: Given IV
analyzed count
111
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00861705-om-0004#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-6ea26642
nct id
NCT00861705
outcome key
om-0004
arm key
OG003
arm label
Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)
regimen
Patients receive pac and ddAC as in arm 1, bev as in arm 2, and carboplatin as in arm 3. doxorubicin hydrochloride: Given IV paclitaxel: Given IV cyclophosphamide: Given IV bevacizumab: Given IV carboplatin: Given IV
analyzed count
110
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00861705-om-0004#groups/OG003

harms

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-6ea26642
nct id
NCT00861705
harm key
EG000
source section id
NCT00861705-ae
event group key
EG000
event group label
Arm 1 (Pac --> ddAC)
serious affected
15
serious at risk
108
other affected
107
other at risk
108
frequency threshold
0
collection period
Source null
event definition
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-6ea26642
nct id
NCT00861705
harm key
EG001
source section id
NCT00861705-ae
event group key
EG001
event group label
Arm 2 (Pac + Bev --> ddAC + Bev)
serious affected
27
serious at risk
108
other affected
104
other at risk
108
frequency threshold
0
collection period
Source null
event definition
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-6ea26642
nct id
NCT00861705
harm key
EG002
source section id
NCT00861705-ae
event group key
EG002
event group label
Arm 3 (Pac + Carboplatin --> ddAC)
serious affected
21
serious at risk
109
other affected
106
other at risk
109
frequency threshold
0
collection period
Source null
event definition
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-6ea26642
nct id
NCT00861705
harm key
EG003
source section id
NCT00861705-ae
event group key
EG003
event group label
Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)
serious affected
39
serious at risk
112
other affected
109
other at risk
112
frequency threshold
0
collection period
Source null
event definition
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice