Active, not recruitingNCT00295893Updated Sep 24, 2026Results posted

Combination Chemotherapy With or Without Trastuzumab in Treating Patients With Stage II or Stage III Breast Cancer

A Phase 2 interventional study of cyclophosphamide and docetaxel in Breast Cancer, sponsored by City of Hope Medical Center. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by City of Hope Medical Center · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 121
Allocation: Randomized
Ages: 18 Years to 120 Years
Sex: All

Study summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving combination chemotherapy with or without trastuzumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether combination chemotherapy is more effective with or without trastuzumab in treating breast cancer.

PURPOSE: This randomized phase II trial is comparing two different regimens of combination chemotherapy given together with or without trastuzumab to see how well they work in treating patients with stage II or stage III breast cancer.

Read the detailed description

OBJECTIVES:

Primary

Compare 2 neoadjuvant chemotherapy regimens (docetaxel, doxorubicin hydrochloride, and cyclophosphamide [TAC] vs doxorubicin and cyclophosphamide followed by paclitaxel and carboplatin [ACAC]), in terms of toxicities and effectiveness as defined by the pathological complete remission rate, in patients with non HER2/neu overexpressing stage II or III breast cancer.
Evaluate the probability of achieving a pathological complete remission when adding trastuzumab (Herceptin®) to ACAC in the subset of patients with HER2/neu overexpressing stage II or III breast cancer.

Secondary

Identify prognostic and predictive markers of outcome, recurrence, and targets of therapy.

OUTLINE: This is a randomized study. Patients with non HER2/neu overexpressing tumors are randomized to 1 of 2 treatment arms. Patients with HER2/neu overexpressing tumors are assigned to arm III.

Arm I: Patients receive doxorubicin hydrochloride IV, cyclophosphamide IV, and docetaxel IV on day 1. Treatment repeats every 21 days for 6 courses.
Arm II: Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1; treatment repeats every 2 weeks for 4 courses. Patients then receive carboplatin IV on day 1 and paclitaxel IV on days 1, 8, and 15; treatment with carboplatin and paclitaxel repeats every 4 weeks for 3 courses.
Arm III: Patients receive chemotherapy as in arm II. They also receive trastuzumab (Herceptin®) IV weekly, beginning with the first doses of paclitaxel and carboplatin.

Within 4 weeks after completion of chemotherapy with or without trastuzumab (Herceptin®), all patients undergo surgery.

PROJECTED ACCRUAL: A total of 105 patients will be accrued for this study.

Conditions studied

Breast Cancer

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Keywords

inflammatory breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
male breast cancer
Paget disease of the breast with invasive ductal carcinoma
invasive ductal breast carcinoma with predominant intraductal component
invasive ductal breast carcinoma
medullary ductal breast carcinoma with lymphocytic infiltrate
comedo ductal breast carcinoma
invasive lobular breast carcinoma with predominant in situ component
invasive lobular breast carcinoma
mucinous ductal breast carcinoma
papillary ductal breast carcinoma
tubular ductal breast carcinoma

Who can participate

Ages eligible: 18 Years to 120 Years
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

DISEASE CHARACTERISTICS:

Histologically proven infiltrating ductal or lobular breast carcinoma
- Stage II or III disease
- Inflammatory breast cancer allowed
Hormone-receptor status not specified

PATIENT CHARACTERISTICS:

ECOG performance status \< 2
Male or female
Menopausal status not specified (for female patients)
Absolute neutrophil count ≥ 1,500/mm\^3
Platelet count ≥ 100,000/mm\^3
Bilirubin normal (except for patient's with Gilbert's disease)
Creatinine ≤ 1.2 mg/dL
Creatinine clearance ≥ 70 mL/min
Ejection fraction ≥ 50% on MUGA
No neuropathy ≥ grade 1
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective nonhormonal contraception
No prior malignant disease within the past 5 years, excluding:
- Squamous cell or basal cell skin carcinoma
- Stage I or in situ cervical carcinoma
No noninvasive (in situ) breast carcinoma within the past 5 years

PRIOR CONCURRENT THERAPY:

At least 5 years since prior antiestrogen treatment for any indication other than breast cancer prevention (tamoxifen, raloxifene, or an aromatase inhibitor)
No prior radiotherapy to the chest wall

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 121 participants (actual)

Study arms

Active comparator
Docetaxel, Doxorubicin Hydrochloride, and Cyclophosphamide
Patients receive doxorubicin hydrochloride IV, cyclophosphamide IV, and docetaxel IV on day 1. Treatment repeats every 21 days for 6 courses.
Drug: cyclophosphamide · Drug: docetaxel · Drug: doxorubicin hydrochloride
Experimental
Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel and Carboplatin
Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1; treatment repeats every 2 weeks for 4 courses. Patients then receive carboplatin IV on day 1 and paclitaxel IV on days 1, 8, and 15; treatment with carboplatin and paclitaxel repeats every 4 weeks for 3 courses.
Drug: cyclophosphamide · Drug: doxorubicin hydrochloride · Drug: Carboplatin · Drug: Paclitaxel
Experimental
Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel, Carboplatin and trastuzumab
Patients receive chemotherapy as in arm II. They also receive trastuzumab (Herceptin®) IV weekly, beginning with the first doses of paclitaxel and carboplatin.
Drug: cyclophosphamide · Drug: doxorubicin hydrochloride · Biological: Trastuzumab · Drug: Carboplatin · Drug: Paclitaxel

Interventions

Drugcyclophosphamide
Given IV
Drugdocetaxel
Given IV
Drugdoxorubicin hydrochloride
Given IV
BiologicalTrastuzumab
Given IV
DrugCarboplatin
Given IV
DrugPaclitaxel
Given IV

What researchers measure

Primary outcomes

Count of Patients With Pathologic Complete Response (pCR)
pCR was defined as no evidence of residual invasive cancer (or very few scattered tumor cells) in primary tumor and lymph nodes.
Time frame: At the time of surgery within 4 weeks of the end of chemotherapy, up to 10 months
Count of Patients With Residual Cancer Burden (RCB) Scores of 0 or 1.
RCB score is determined using information on the size of the tumor and the extent of tumor cells in the breast and axillary lymph nodes after neoadjuvant therapy. The higher the RCB score, the more residual breast cancer there is in the breast and lymph nodes: RCB-0 = No residual breast cancer RCB-I = Small amount of residual breast cancer RCB-II = Moderate amount of residual breast cancer RCB-III = Extensive (a lot of) residual breast cancer
Time frame: At the time of surgery within 4 weeks of the end of chemotherapy, up to 10 months.

Results

Posted Mar 14, 2023

Participant flow

Participant flow — Overall Study
Milestone	Docetaxel, Doxorubicin Hydrochloride, and Cyclophosphamide	Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel and Carboplatin	Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel, Carboplatin and Trastuzumab
Started	37	40	44
Completed	37	40	44
Not completed	0	0	0

Outcome measures

PrimaryCount of Patients With Pathologic Complete Response (pCR)

pCR was defined as no evidence of residual invasive cancer (or very few scattered tumor cells) in primary tumor and lymph nodes.

Time frame:: At the time of surgery within 4 weeks of the end of chemotherapy, up to 10 months
Reported as:: Count of participants · Participants

Count of Patients With Pathologic Complete Response (pCR)
Participants	Docetaxel, Doxorubicin Hydrochloride, and Cyclophosphamide	Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel and Carboplatin	Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel, Carboplatin and Trastuzumab
Count of Patients With Pathologic Complete Response (pCR)	6	4	22

PrimaryCount of Patients With Residual Cancer Burden (RCB) Scores of 0 or 1.

RCB score is determined using information on the size of the tumor and the extent of tumor cells in the breast and axillary lymph nodes after neoadjuvant therapy. The higher the RCB score, the more residual breast cancer there is in the breast and lymph nodes: RCB-0 = No residual breast cancer RCB-I = Small amount of residual breast cancer RCB-II = Moderate amount of residual breast cancer RCB-III = Extensive (a lot of) residual breast cancer

Time frame:: At the time of surgery within 4 weeks of the end of chemotherapy, up to 10 months.
Reported as:: Count of participants · Participants

Count of Patients With Residual Cancer Burden (RCB) Scores of 0 or 1.
Participants	Docetaxel, Doxorubicin Hydrochloride, and Cyclophosphamide	Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel and Carboplatin	Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel, Carboplatin and Trastuzumab
Count of Patients With Residual Cancer Burden (RCB) Scores of 0 or 1.	11	10	28

Adverse events

Collected over Adverse events occurred over a period of 2 years and 7 months.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Docetaxel, Doxorubicin Hydrochloride, and Cyclophosphamide	2/37 (5.4%)	8/37 (21.6%)	37/37 (100%)
Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel and Carboplatin	4/40 (10%)	5/40 (12.5%)	40/40 (100%)
Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel, Carboplatin and Trastuzumab	4/44 (9.1%)	8/44 (18.2%)	44/44 (100%)

Most frequent serious events

Showing 10 of 37

Most frequent serious events
Event	Docetaxel, Doxorubicin Hydrochloride, and Cyclophosphamide	Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel and Carboplatin	Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel, Carboplatin and Trastuzumab
Febrile neutropeniaBlood and lymphatic system disorders	5/37	0/40	0/44
Skin infectionInfections and infestations	1/37	0/40	3/44
Neutrophil count decreasedInvestigations	2/37	0/40	1/44
DyspneaRespiratory, thoracic and mediastinal disorders	0/37	2/40	2/44
DiarrheaGastrointestinal disorders	0/37	1/40	2/44
Cardiac painCardiac disorders	1/37	0/40	0/44
PericarditisCardiac disorders	1/37	0/40	0/44
PainGeneral disorders	1/37	1/40	1/44
BronchitisInfections and infestations	1/37	0/40	0/44
Soft tissue infectionInfections and infestations	1/37	0/40	0/44

Most frequent other events

Showing 10 of 238

Most frequent other events
Event	Docetaxel, Doxorubicin Hydrochloride, and Cyclophosphamide	Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel and Carboplatin	Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel, Carboplatin and Trastuzumab
FatigueGeneral disorders	35/37	40/40	43/44
Hemoglobin decreasedBlood and lymphatic system disorders	30/37	39/40	43/44
Aspartate aminotransferase increasedInvestigations	31/37	37/40	37/44
NauseaGastrointestinal disorders	30/37	36/40	40/44
Peripheral sensory neuropathyNervous system disorders	28/37	33/40	40/44
AlopeciaSkin and subcutaneous tissue disorders	26/37	32/40	33/44
ConstipationGastrointestinal disorders	18/37	23/40	35/44
Alanine aminotransferase increasedInvestigations	25/37	25/40	34/44
Neutrophil count decreasedInvestigations	19/37	29/40	32/44
Leukocyte count decreasedInvestigations	14/37	27/40	30/44

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Docetaxel, Doxorubicin Hydrochloride, and Cyclophosphamide	Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel and Carboplatin	Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel, Carboplatin and Trastuzumab	Total
Median	50 (33 to 65)	49 (31 to 68)	52 (30 to 70)	50 (30 to 70)

Sex: Female, Male
Sex: Female, Male(Participants)	Docetaxel, Doxorubicin Hydrochloride, and Cyclophosphamide	Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel and Carboplatin	Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel, Carboplatin and Trastuzumab	Total
Female	37	40	44	121
Male	0	0	0	0

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Docetaxel, Doxorubicin Hydrochloride, and Cyclophosphamide	Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel and Carboplatin	Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel, Carboplatin and Trastuzumab	Total
American Native	1	0	0	1
Asian	2	1	10	13
African American	1	3	3	7
White	19	17	19	55
Hispanic	14	19	12	45

Region of Enrollment
Region of Enrollment(participants)	Docetaxel, Doxorubicin Hydrochloride, and Cyclophosphamide	Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel and Carboplatin	Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel, Carboplatin and Trastuzumab	Total
United States	37	40	44	121

Study locations

1 site

City of Hope Medical Center
Duarte, California 91010-3000, United States

References and documents

Study documents

Protocol and statistical analysis plan · Mar 17, 2009

Documents are hosted by the registry — open the source record to download them.

Registry details

Key details

Study ID: NCT00295893
Lead sponsor: City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)
Responsible party: Sponsor
First posted: Feb 24, 2006
Start date: Sep 27, 2005
Primary completion: Dec 30, 2013
Completion: Jul 16, 2027 (estimated)
Results posted: Mar 14, 2023
Last update: Sep 24, 2026

Study contacts

Joanne Mortimer, MD

principal investigator · City of Hope Medical Center

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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