NCT02488967|Active Not RecruitingPhase 3DMC

Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel With or Without Carboplatin in Treating Patients With Triple-Negative Breast Cancer

A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel With or Without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer

NRG Oncology ClinicalTrials.gov

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4 other identifiers

NRG-BR003NCI-2015-00128NRG-BR1428U10CA180868

Study Type

interventional

Target

782

Locations

2 countries

Sites

1296

Timeline

RegisteredJul 2015

StartedJul 2015

CompletionOct 2026

Brief Summary

This randomized phase III trial studies how well doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel with or without carboplatin work in treating patients with triple-negative breast cancer. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether doxorubicin hydrochloride and cyclophosphamide is more effective when followed by paclitaxel alone or paclitaxel and carboplatin in treating triple-negative breast cancer.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

782

participants targeted

Target at P75+ for phase_3

Timeline

6mo left

Started Jul 2015

Longer than P75 for phase_3

Geographic Reach

2 countries

1296 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

11.3 years study duration

Study Progress96%

Jul 2015Oct 2026

First Submitted

Initial submission to the registry

June 30, 2015

Completed

2 days until next milestone

First Posted

Study publicly available on registry

July 2, 2015

Completed

24 days until next milestone

Study Start

First participant enrolled

July 26, 2015

Completed

10.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed

10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Expected

Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

10.4 years

First QC Date

June 30, 2015

Last Update Submit

May 5, 2026

Conditions

Breast Adenocarcinoma HER2/Neu Negative Estrogen Receptor Negative Progesterone Receptor Negative Stage IB Breast Cancer Stage IIA Breast Cancer Stage IIB Breast Cancer Stage IIIA Breast Cancer Stage IIIC Breast Cancer Triple-Negative Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

IDFS
IDFS events are local invasive recurrence after mastectomy, local invasive recurrence in the ipsilateral breast after lumpectomy, regional recurrence, distant recurrence, contralateral invasive breast cancer, second non-breast primary cancer (excluding squamous or basal cell carcinoma of the skin), or death from any cause before recurrence or second primary cancer. IDFS will be compared between the two treatment arms by the stratified log-rank test. The Kaplan-Meier estimates will be calculated separately for patients under the different treatment regimens.
Up to 10 years

Secondary Outcomes (5)

BCFS
From randomization until local recurrence (invasive or DCIS), regional recurrence, or distant recurrence, contralateral breast cancer (invasive or DCIS), or death from any causes, assessed up to 10 years
DRFI
From randomization until distant metastasis or death from breast cancer, regardless of occurrence of any intervening local or regional recurrences, contralateral breast cancers, or non-breast second primary cancers, assessed up to 10 years
Frequencies of adverse events categorized using the National Cancer Institute CTCAE v4.0
Up to 10 years
OS
From randomization until death from any cause, assessed up to 10 years
RFI
From randomization until invasive local, regional, or distant recurrence, or death from breast cancer (censored for death from other causes), assessed up to 10 years

Study Arms (2)

Arm I (AC-->WP)

ACTIVE COMPARATOR

Patients receive doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive paclitaxel IV over 60 minutes on day 1. Treatment repeats weekly for 12 courses in the absence of disease progression or unacceptable toxicity.

Drug: CyclophosphamideDrug: Doxorubicin HydrochlorideOther: Laboratory Biomarker AnalysisDrug: Paclitaxel

Arm II (AC-->WP + carboplatin)

EXPERIMENTAL

Patients receive doxorubicin hydrochloride and cyclophosphamide as in Arm I. Patients then receive paclitaxel IV over 60 minutes on days 1, 8, and 15 and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.

Drug: CarboplatinDrug: CyclophosphamideDrug: Doxorubicin HydrochlorideOther: Laboratory Biomarker AnalysisDrug: Paclitaxel

Interventions

CarboplatinDRUG

Given IV

Also known as: Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplat, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo

Arm II (AC-->WP + carboplatin)

CyclophosphamideDRUG

Given IV

Also known as: (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR- 138719

Arm I (AC-->WP)Arm II (AC-->WP + carboplatin)

Doxorubicin HydrochlorideDRUG

Given IV

Also known as: 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI), ADM, Adriacin, Adriamycin, Adriamycin Hydrochloride, Adriamycin PFS, Adriamycin RDF, ADRIAMYCIN, HYDROCHLORIDE, Adriamycine, Adriblastina, Adriblastine, Adrimedac, Chloridrato de Doxorrubicina, DOX, DOXO-CELL, Doxolem, Doxorubicin.HCl, Doxorubin, Farmiblastina, FI 106, FI-106, hydroxydaunorubicin, Rubex

Arm I (AC-->WP)Arm II (AC-->WP + carboplatin)

Laboratory Biomarker AnalysisOTHER

Correlative studies

Arm I (AC-->WP)Arm II (AC-->WP + carboplatin)

PaclitaxelDRUG

Given IV

Also known as: Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat

Arm I (AC-->WP)Arm II (AC-->WP + carboplatin)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

The patient must have signed and dated an institutional review board (IRB)-approved consent form that conforms to federal and institutional guidelines
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination
All of the following staging criteria (according to the 7th edition of the American Joint Committee on Cancer \[AJCC\] Cancer Staging Manual) must be met:
By pathologic evaluation, primary tumor must be pT1-3
By pathologic evaluation, ipsilateral nodes must be pN0, pN1 (pN1mi, pN1a, pN1b, pN1c), pN2a, pN2b, pN3a, or pN3b
If pN0, pathological tumor must be greater than or equal to 3.0 cm
The tumor must have been determined to be human epidermal growth factor receptor 2 (HER2)-negative as follows:
Immunohistochemistry (IHC) 0-1+; or
IHC 2+ and in situ hybridization (ISH) non-amplified with a ratio of HER2 to centromere enumerator probe 17 (CEP17) less than 2.0, and if reported, average HER2 gene copy number less than 4 signals/cells; or
ISH non-amplified with a ratio of HER2 to CEP17 less than 2.0, and if reported, average HER2 gene copy number less than 4 signals/cells
The tumor must have estrogen receptor (ER)-and progesterone receptor (PgR)-status assessed using current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines; patients are eligible if the tumor staining meets one of the following criteria:
ER-negative and PgR-negative by ASCO/CAP guidelines, OR
ER or PgR stains are positive in 1-9% of cells and neither is positive in greater than or equal to 10% of cells.
The patient must have undergone either a mastectomy (total, skin-sparing, or nipple-sparing) or lumpectomy
+19 more criteria

You may not qualify if:

T4 tumors including inflammatory breast cancer
Definitive clinical or radiologic evidence of metastatic disease; required imaging studies must have been performed within 90 days prior to randomization
Synchronous or previous contralateral invasive breast cancer; (patients with synchronous and/or previous contralateral DCIS or LCIS are eligible)
Any previous history of ipsilateral invasive breast cancer or ipsilateral DCIS; (patients with synchronous or previous ipsilateral LCIS are eligible)
History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to randomization
Previous therapy with anthracyclines or taxanes for any malignancy
Chemotherapy administered for the currently diagnosed breast cancer prior to randomization
Any continued use of sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy; patients are eligible if these medications are discontinued prior to randomization
Cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimens; this includes but is not confined to:
Active cardiac disease
Angina pectoris that requires the current use of anti-anginal medication;
Ventricular arrhythmias except for benign premature ventricular contractions;
Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication;
Conduction abnormality requiring a pacemaker;
Valvular disease with documented compromise in cardiac function; or
+19 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

NRG Oncologylead
National Cancer Institute (NCI)collaborator

Study Sites (1296)

Southern Cancer Center PC-Mobile

Mobile, Alabama, 36607, United States

Location

Southern Cancer Center PC-Providence

Mobile, Alabama, 36608, United States

Location

Southern Cancer Center PC-Springhill

Mobile, Alabama, 36608, United States

Location

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, 98508, United States

Location

Anchorage Radiation Therapy Center

Anchorage, Alaska, 99504, United States

Location

Alaska Breast Care and Surgery LLC