NCT00542451 · CITED IN SOURCE DOCUMENTS

Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2024-06-26

The purpose of this study is to find out what effect the postoperative combination of therapies: trastuzumab (herceptin) and paclitaxel (taxol) will have on breast cancer recurrence. A combination of trastuzuamb and chemotherapy has been used in women with node positive and high risk node negative disease. This tests utilizes a well tolerated regimen of weekly paclitaxel and trastuzumab in women with T1, node negative tumors that are HER2 positive. We would like to determine how effective this drug combination is when used in women with early stage breast cancer, as well as to better define the side effects of this treatment.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

3-year Disease Free Survival (DFS) Rate

→

outcome · POSTED

Disease Free Survival (DFS) in Patients With Tumors Measuring ≤1 cm or > 1 cm

→

outcome · POSTED

Number of Patients With Grade III/IV Cardiac Left Ventricular Dysfunction

→

outcome · POSTED

Number of Patients With Grade III/IV Neurotoxicity

→

outcome · POSTED

Number of Patients With Amenorrhea

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→

Who could take part

eligibility Criteria: Inclusion Criteria: * Histologically confirmed invasive carcinoma of the breast * Tumors must be less than or equal to 3cm in greatest dimension * Must have node-negative breast cancer according to teh AJCC 7th edition * ER/PR determination is required. ER- and PR-assays should be performed by immunohistochemical methods * HER-2 positive: IHC 3+ or FISH \>2 * Bilateral breast cancers that individually meet eligibility criteria are allowed * Patients should have tumor tissue available, and a tissue block of sufficient size to make 15 slides must be sent to DFCI for testing * Less than or equal to 84 days from mastectomy or from axillary dissection or sentinel node biopsy if the patient's most extensive breast surgery was a breast-sparing procedure * All tumor should be removed by either a modified radical mastectomy or a segmental mastectomy (lumpectomy), with either a sentinel node biopsy or axillary dissection * 18 years of age or older * ECOG Performance Status of 0 or 1 * Adequate bone marrow function, hepatic function, and renal function as outlined in protocol * Left ventricular ejection fraction of greater than or equal to 50% * Willingness to discontinue any hormonal agent prior to registration and while on study * Willingness to discontinue sex hormonal therapy, e.g. birth control pills, prior to registration and while on study * Patients with a history of ipsilateral DCIS are eligible if they were treated with wide-excision alone, without radiation therapy * Patients undergoing breast conservation therapy must not have any contraindications to radiation therapy Exclusion Criteria: * Pregnant or nursing women * Locally advanced tumors at diagnosis, including tumors fixed to the chest wall, peau d'orange, skin ulcerations/nodules, or clinical inflammatory changes * History of prior chemotherapy in past 5 years * History of prior trastuzumab therapy * Active, unresolved infection * Prior history of any other malignancy in the past 5 years, except for early stage tumors of the skin or cervix treated with curative intent * Sensitivity to benzyl alcohol * Grade 2 or greater neuropathy per NCI's CTCAv3.0. (Exception: Any chronic neurologic disorder will be looked at on a case-by-case basis by the study chair). * Active cardiac disease as outlined in protocol.
healthy Volunteers: false
minimum Age: 18 Years
sex: FEMALE
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
80 mg of paclitaxel per square meter of body-surface area weekly for 12 weeks and a loading dose of 4 mg of intravenous trastuzumab per kilogram of body weight on day 1, followed by 2 mg per kilogram weekly, for a total of 12 doses. After the completion of 12 weeks of treatment with Trastuzumab, the dosing of Trastuzumab could be continued on a weekly basis, or the regimen could be changed to 6 mg per kilogram every 3 weeks for 40 weeks to complete a full year of intravenous treatment with trastuzumab.
intervention Names
Drug: Paclitaxel
Drug: Trastuzumab
label
Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer
type
EXPERIMENTAL

interventions

arm Group Labels
Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer
description
Every week for 12 weeks
name
Paclitaxel
other Names
Taxol
type
DRUG
arm Group Labels
Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer
description
Once a week for twelve weeks Then once a week or once every three weeks for 40 weeks
name
Trastuzumab
other Names
Herceptin
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 406
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Disease-free survival (DFS) is the proportion of participants ramaing disease free at 3 years based on the Kaplan-Meier method. DFS is defined to end at the time of the first of the following events: local/regional ipsilateral invasive recurrence (or ipsilateral invasive new primary), contralateral invasive breast cancer, distant recurrence, or death from any cause.
measure
3-year Disease Free Survival (DFS) Rate
time Frame
at 3 years

secondary Outcomes

description
DFS is defined as the time from registration to the first of the following events: local/regional ipsilateral invasive recurrence (or ipsilateral invasive new primary), contralateral invasive breast cancer, distant recurrence, or death from any cause. Patients without an event are censored at the date of last evaluation.
measure
Disease Free Survival (DFS) in Patients With Tumors Measuring ≤1 cm or > 1 cm
time Frame
at 3 years
description
cardiac left ventricular dysfunction related adverse events (AE) with any attribution of possibly, probably or definite based on CTCAEv3 as reported on case report forms were counted.
measure
Number of Patients With Grade III/IV Cardiac Left Ventricular Dysfunction
time Frame
AE evaluated on treatment every week during paclitaxel and every 9 weeks during trastuzumab monotheryapy, and at progression, and observation years 2-10. Median treatment duration was 11.4 months (range 0 - 23.5 months).
description
Nervous system disorders related adverse events (AE) with any attribution of possibly, probably or definite based on CTCAEv3 as reported on case report forms were counted.
measure
Number of Patients With Grade III/IV Neurotoxicity
time Frame
AE evaluated on treatment every week during paclitaxel and every 9 weeks during trastuzumab monotheryapy, and at progression, and observation years 2-10. Median treatment duration was 11.4 months (range 0 - 23.5 months).
description
Patients that eligible for amenorrhea assessment and data collecting will be evaluated by standard method defined per protocol 3.9, through menses assessment survey.
measure
Number of Patients With Amenorrhea
time Frame
Menses Assessment survey on Q6 months x 1 year, then q6months for year 2 and at progression, and observation years 2-10 or until progression.

Full study description

brief Summary: The purpose of this study is to find out what effect the postoperative combination of therapies: trastuzumab (herceptin) and paclitaxel (taxol) will have on breast cancer recurrence. A combination of trastuzuamb and chemotherapy has been used in women with node positive and high risk node negative disease. This tests utilizes a well tolerated regimen of weekly paclitaxel and trastuzumab in women with T1, node negative tumors that are HER2 positive. We would like to determine how effective this drug combination is when used in women with early stage breast cancer, as well as to better define the side effects of this treatment.
detailed Description: * Participants will enroll in this study at the time they are starting their adjuvant therapy for breast cancer. Participants will receive chemotherapy with paclitaxel every week for 12 weeks. They will begin to receive trastuzumab at the same time they begin paclitaxel. Once they have completed the 12 weeks of paclitaxel and trastuzumab, they will receive trastuzumab every 3 weeks or weekly for 40 weeks. * Participants will be followed with routine assessments such as physical exam and vital signs every 3 months for the first year, and then every 6 months for years 2-5. Then we would like to keep track of the participants medical condition by calling them on the telephone once per year.

Source references

references

citation
Tolaney SM, Tarantino P, Graham N, Tayob N, Pare L, Villacampa G, Dang CT, Yardley DA, Moy B, Marcom PK, Albain KS, Rugo HS, Ellis MJ, Shapira I, Wolff AC, Carey LA, Barroso-Sousa R, Villagrasa P, DeMeo M, DiLullo M, Zanudo JGT, Weiss J, Wagle N, Partridge AH, Waks AG, Hudis CA, Krop IE, Burstein HJ, Prat A, Winer EP. Adjuvant paclitaxel and trastuzumab for node-negative, HER2-positive breast cancer: final 10-year analysis of the open-label, single-arm, phase 2 APT trial. Lancet Oncol. 2023 Mar;24(3):273-285. doi: 10.1016/S1470-2045(23)00051-7.
pmid
36858723
type
DERIVED
citation
Tolaney SM, Guo H, Pernas S, Barry WT, Dillon DA, Ritterhouse L, Schneider BP, Shen F, Fuhrman K, Baltay M, Dang CT, Yardley DA, Moy B, Marcom PK, Albain KS, Rugo HS, Ellis MJ, Shapira I, Wolff AC, Carey LA, Overmoyer B, Partridge AH, Hudis CA, Krop IE, Burstein HJ, Winer EP. Seven-Year Follow-Up Analysis of Adjuvant Paclitaxel and Trastuzumab Trial for Node-Negative, Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer. J Clin Oncol. 2019 Aug 1;37(22):1868-1875. doi: 10.1200/JCO.19.00066. Epub 2019 Apr 2.
pmid
30939096
type
DERIVED
citation
Barroso-Sousa R, Barry WT, Guo H, Dillon D, Tan YB, Fuhrman K, Osmani W, Getz A, Baltay M, Dang C, Yardley D, Moy B, Marcom PK, Mittendorf EA, Krop IE, Winer EP, Tolaney SM. The immune profile of small HER2-positive breast cancers: a secondary analysis from the APT trial. Ann Oncol. 2019 Apr 1;30(4):575-581. doi: 10.1093/annonc/mdz047.
pmid
30753274
type
DERIVED
citation
Tolaney SM, Barry WT, Dang CT, Yardley DA, Moy B, Marcom PK, Albain KS, Rugo HS, Ellis M, Shapira I, Wolff AC, Carey LA, Overmoyer BA, Partridge AH, Guo H, Hudis CA, Krop IE, Burstein HJ, Winer EP. Adjuvant paclitaxel and trastuzumab for node-negative, HER2-positive breast cancer. N Engl J Med. 2015 Jan 8;372(2):134-41. doi: 10.1056/NEJMoa1406281.
pmid
25564897
type
DERIVED

Source notices and limitations

Discovery and provenance

release id
ctgov-registry-7ad944f6deaf1f5cd6122126
edge id
nct-edge-44fb3955a1d10fad401a
requested nct id
NCT00542451
primary nct id
NCT00542451
source kind
nci_explicit_reference_or_link
source url
https://www.cancer.gov/types/breast/hp/breast-treatment-pdq
source record id
Source null
source file sha256
862f78faa9e4cbedc19f9ffcaeba97e029ba51b72bb3b81fc67aa8b6adf96904
payload sha256
23e9369831c8aae2476436cfd537d38bb504d967255401e74b5c4a14fdd5d44f
payload
clinical indication matching status
not_inferred
end exclusive
true
id
nct-edge-44fb3955a1d10fad401a
link basis
explicit_NCT_identifier_in_acquired_source
nct id
NCT00542451
occurrences
context exact
R2-positive tumors):</p> <div class="pdq-content-list"><ol id="_3316"><li>The single-arm Adjuvant Paclitaxel and Trastuzumab (<a href="/clinicaltrials/NCT00542451">APT</a>) trial (NCT00542451) evaluated a non–anthracycline-containing regimen, paclitaxel and trastuzumab. The trial enrolled 410 women with node-negati
end
431162
exact text
NCT00542451
start
431151
context exact
<div class="pdq-content-list"><ol id="_3316"><li>The single-arm Adjuvant Paclitaxel and Trastuzumab (<a href="/clinicaltrials/NCT00542451">APT</a>) trial (NCT00542451) evaluated a non–anthracycline-containing regimen, paclitaxel and trastuzumab. The trial enrolled 410 women with node-negative, small (≤3 cm), HER2
end
431191
exact text
NCT00542451
start
431180
offset unit
unicode_code_points
source file
/tmp/cancer-full-research/nci/raw/29bf1e5a1d739974ed.html
source file sha256
862f78faa9e4cbedc19f9ffcaeba97e029ba51b72bb3b81fc67aa8b6adf96904
source json pointer
Source null
source kind
nci_explicit_reference_or_link
source record id
Source null
source retrieved at
2026-09-09T23:21:35.419733+00:00
source string basis
UTF-8_text_with_universal_newline_translation
source string sha256
536430925e3b0008edd3fb69a869d5645bd6b6dc5c84c21ddf1b3e24f089874c
source title
Breast Cancer Treatment (PDQ®)–Health Professional Version
source update dates
context
Updated: April 25, 2025
datetime
2025-04-25T12:00:00Z
display
April 25, 2025
source url
https://www.cancer.gov/types/breast/hp/breast-treatment-pdq

Preserved source evidence · Not medical advice