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
Among 373 studies testing trastuzumab in Breast Neoplasms — 56 open to participants now, 85 under way, 5 of them phase 3. Trastuzumab · Breast Neoplasms.
Among the 373 studies testing trastuzumab in Breast Neoplasms, this one is the 104th largest by enrollment of the 365 interventional ones that give a count, is one of 15 that started in 2005, is one of 239 in phase 2, reaches primary completion later than 0 of the 84 other live ones, and was the 66th registered.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
Browse Breast Neoplasms studies →56 of the 373 studies testing trastuzumab in Breast Neoplasms are open now, in 12 countries. Recruiting first, the newest first:
SWOG Cancer Research Network · Sites in United States
Ages 18+
Duke University · Sites in United States
Ages 18+ · Women only
Rutgers, The State University of New Jersey · Sites in United States
Ages 18–90
Shanghai Jiao Tong University School of Medicine · Sites in China
Ages 18–70 · Women only
Institut Curie · Sites in France
Ages 18+
By country, each count listing its studies:
Trastuzumab: first FDA approval 1998 (HERCEPTIN), first EMA approval 2000. What it is approved for, and how studies give it, is on its page →
Of the 2,400 Breast Neoplasms studies recruiting now, 1,572 (66%) set no upper age limit and 591 (25%) stop at 75 or younger; 103 take children under 18; 214 take healthy volunteers.
This study: 18 Years to 120 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
On this site’s reading of the record, trastuzumab is the treatment under test here. Read study by study →
373 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 50 · Phase 2 270 · Phase 3 61 · Phase 4 7
First in 1998; this study’s year is marked. 15 started in 2005.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 121 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Median enrollment 62 across the 365 interventional studies. Of the 235 that completed or were terminated, 128 (54%) have results posted.
This tab as a report to print or save as PDF → With an account.
73 of 373 have an industry lead sponsor. The 10 most frequent:
City of Hope Medical Center is the lead sponsor of 677 studies on the registry; 181 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 12 (39%) have results posted.
89 studies in Breast Neoplasms by City of Hope Medical Center: 17 open now, 39 under way, 1 of them phase 3. Of 43 finished, 14 (33%) have results posted.
Among the 89 studies in Breast Neoplasms by City of Hope Medical Center, this one is the 10th largest by enrollment of the 76 interventional ones that give a count, is one of 5 that started in 2005, is one of 25 in phase 2, reaches primary completion later than 1 of the 38 other live ones, and was the 11th registered.
City of Hope Medical Center’s Breast Neoplasms studies by the year they started, since 1994.
22 of the studies testing trastuzumab in Breast Neoplasms that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06035679Youzhi ZhuPyrotinib Combined With Trastuzumab and Chemotherapy Neoadjuvant Therapy for HER2-positive Breast Cancer | 2026-11-30 |
| NCT05891561Shanghai Jiao Tong University School of MedicineShort-course Trastuzumab, Pertuzumab with Taxanes in the Adjuvant Treatment of Early HER2-positive Breast Cancer | 2026-12 |
| NCT04886531Ruth O'ReganTrial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers | 2026-12-22 |
| NCT07095023Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityNeoadjuvant Oral Paclitaxel Plus Subcutaneous Pertuzumab/Trastuzumab in Patients With HER2-positive Breast Cancer | 2026-12-30 |
| NCT07635342Hebei Medical University Fourth HospitalPyrotinib Plus Trastuzumab and Chemotherapy for HER2-Positive Early Breast Cancer | 2026-12-31 |
Among the 373 studies testing trastuzumab in Breast Neoplasms, from their registry updates:
Among City of Hope Medical Center’s 89 in Breast Neoplasms:
This tab as a report to print or save as PDF → With an account.
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.
OBJECTIVES:
Primary
Secondary
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.
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.
DISEASE CHARACTERISTICS:
proven infiltrating ductal or lobular breast carcinoma
PATIENT CHARACTERISTICS:
No prior malignant disease within the past 5 years, excluding:
PRIOR CONCURRENT THERAPY:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
Given IV
Given IV
Given IV
Given IV
Given IV
Given IV
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.
| 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 |
pCR was defined as no evidence of residual invasive cancer (or very few scattered tumor cells) in primary tumor and lymph nodes.
| 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 |
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
| 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 |
Collected over Adverse events occurred over a period of 2 years and 7 months.. Non-serious events are listed at a 0% frequency threshold.
| 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%) |
| 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 |
| 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 |
| 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(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(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(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 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Sep 2005 to primary completion in Dec 2013, 99 months.
Results were first posted in Mar 2023, 9 years 2 months after primary completion.
Of 1,070 non-industry phase 2 interventional studies under Breast Neoplasms, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 87. This study's 99 months is above that.
Counting every sponsor, half of 1,302 studies reached it within 51 months; a quarter within 30 and three quarters within 82.
How these figures are worked out, and which studies are left out of them.
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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Studies of the drugs tested here: Trastuzumab · Carboplatin