The Trial Comparing Dose-dense AC-T With PC as Adjuvant Therapy for TNBC

NCT01378533 | Unknown Phase 3 DMC

• 1 other identifier: CH-BC-012
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to compare the 3 years DFS of dose-dense epirubicin and cyclophosphamide followed by paclitaxel with paclitaxel plus carboplatin as adjuvant therapy for triple-negative breast cancer. The other purpose of this trial is to observe the patient's tolerance.

Conditions

Breast Cancer

Keywords

triple-negative breast cancer; dose-dense; epirubicin and cyclophosphamide followed by paclitaxel（AC-T）; paclitaxel plus carboplatin（PC）; 3 years DFS; the tolerance

Outcome Measures

Primary Outcomes (1)

• 3 years DFS

  the participants will be followed by the telephone for the duration, an expected average of 3 years.

  3 years

Secondary Outcomes (1)

• Toxicity as assessed by NCI CTCAE v3.0

  3 years

Study Arms (2)

AC-T（dose-dense）

EXPERIMENTAL

AC-T(dose-dense) EPI（Pharmorubicin） CTX（cyclophosphamide） PTX（Paclitaxel） G-CSF

Drug: epirubicin, cyclophosphamide, paclitaxel, carboplatin, G-CSF

chemotherapy:PC

EXPERIMENTAL

PTX（Paclitaxel） CBP（carboplatin）

Drug: epirubicin, cyclophosphamide, paclitaxel, carboplatin, G-CSF

Interventions

epirubicin, cyclophosphamide, paclitaxel, carboplatin, G-CSF DRUG

epirubicin 80mg/m2 iv d1 or divide in two days cyclophosphamide 600mg/m2 iv d1 G-CSF 3ug/kg ih d5-9 q14d\*4cycles paclitaxel 175mg/m2 iv d1 G-CSF 3ug/kg ih d5-9 q14d\*4cycles paclitaxel 150mg/m2 iv d1 carboplatin AUC=3 iv d2 G-CSF 3ug/kg ih d5-9 q14d\*8cycles

Also known as: pharmorubicin

AC-T（dose-dense）; chemotherapy:PC

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must accept the modified radical mastectomy
• Patients with histologically confirmed ER(-) PR(-) and HER-2(-)
• Positive axillary lymph nodes;negative axillary lymph node with age\< 35 years or Ⅲ grade or intravascular cancer embolus.
• Age between 18 years to 65 years
• Able to give informed consent
• Patients with an Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.
• Not pregnant, and on appropriate birth control if of child-bearing potential.
• Adequate bone marrow reserve with ANC \> 1000 and platelets \> 100,000.
• Adequate renal function with serum creatinine \< 2.0.
• Adequate hepatic reserve with serum bilirubin \< 2.0, AST/ALT \< 2X the upper limit of normal, and alkaline phosphatase \< 5X the upper limit of normal. Serum bilirubin \> 2.0 is acceptable in the setting of known Gilbert's syndrome.
• No active major medical or psychosocial problems that could be complicated by study participation.

You may not qualify if:

• received neo-adjuvant therapy
• Cardiac dysfunction documented by an ejection fraction less than the lower limit of the facility normal by multi-gated acquisition (MUGA) scan, or 45% by echocardiogram. -The rate of Disease recurrence
• Uncontrolled medical problems.
• Evidence of active acute or chronic infection.
• Pregnant or breast feeding.
• Hepatic, renal, or bone marrow dysfunction as detailed above.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer institute and hospital Chinese academy of medical sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

Epirubicin; Cyclophosphamide; Paclitaxel; Carboplatin; Granulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Coordination Complexes; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• qing li, bachelor

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  STUDY CHAIR

Central Study Contacts

qing li, bachelor

CONTACT

0086-010-87788120; cheryliqing@yahoo.cn

ying han, master

CONTACT

0086-010-87788120; huani8023@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: June 17, 2011
• First Posted: June 22, 2011
• Study Start: May 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: June 1, 2013
• Last Updated: December 28, 2011

Record last verified: 2011-12

Locations

CN (1)