## Protocol Section
### Identification Module
**NCT ID:** NCT00002679

**Brief Title:** Adjuvant High-Dose, Sequential Chemotherapy in Treating Patients With Resected Breast Cancer

**Official Title:** Sequential Adjuvant Chemotherapy With Doxorubicin, Taxol, and Cyclophosphamide for Stage II or III Resectable Breast Cancer With Four or More Involved Axillary Lymph Nodes

#### Organization Study ID Info
**ID:** CDR0000064337
#### Organization
**Class:** OTHER
**Full Name:** Yale University
#### Secondary ID Infos
**ID:** YALE-HIC-7374
**ID:** NCI-V95-0720
### Status Module
#### Completion Date
**Date:** 2002-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2009-08-26

**Type:** ESTIMATED

**Last Update Submit Date:** 2009-08-24

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2002-01

**Type:** ACTUAL

#### Start Date
**Date:** 1994-02

**Status Verified Date:** 2009-08

#### Study First Post Date
**Date:** 2004-02-06
**Type:** ESTIMATED
**Study First Submit Date:** 1999-11-01
**Study First Submit QC Date:** 2004-02-05
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Yale University

#### Responsible Party

**Old Name Title:** Maysa Abu-Khalaf, MD, Principal Investigator

**Old Organization:** Yale University School of Medicine

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of high-dose sequential chemotherapy as adjuvant therapy in treating patients with stage II or stage III breast cancer who have four or more positive axillary lymph nodes.

**Detailed Description:** OBJECTIVES: I. Evaluate the efficacy of dose intensive, sequential adjuvant chemotherapy with doxorubicin, paclitaxel, and cyclophosphamide in patients with stage II/III resected breast cancer. II. Evaluate the toxicity of this regimen in these patients.

OUTLINE: All patients receive sequential chemotherapy regimens consisting of 3 courses each of doxorubicin, paclitaxel, and cyclophosphamide on a schedule of one course every 14 days. Following completion of chemotherapy, patients who underwent breast conservation surgery receive radiotherapy. Mastectomy patients with 10 or more positive nodes or with T3-4 tumors are also eligible for delayed radiotherapy. Patients who are hormone receptor positive (or whose receptor status is unknown) are treated with oral tamoxifen for 5 years, beginning after completion of all other therapy. Patients are followed every 3 months for 2 years, every 6 months for 3 years, then yearly.

PROJECTED ACCRUAL: At total of 90 patients will be entered.

### Conditions Module

**Conditions:**

- Breast Cancer

**Keywords:**

- stage II breast cancer

- stage IIIA breast cancer

- male breast cancer

### Design Module

#### Design Info

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 89

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** filgrastim

**Type:** BIOLOGICAL

#### Intervention 2

**Name:** cyclophosphamide

**Type:** DRUG

#### Intervention 3

**Name:** doxorubicin hydrochloride

**Type:** DRUG

#### Intervention 4

**Name:** paclitaxel

**Type:** DRUG

#### Intervention 5

**Name:** tamoxifen citrate

**Type:** DRUG

#### Intervention 6

**Name:** radiation therapy

**Type:** RADIATION

### Eligibility Module

**Eligibility Criteria:** DISEASE CHARACTERISTICS: Histologically proven adenocarcinoma of the breast with involvement of 4 or more axillary nodes, including any T N1 M0 Concurrent bilateral breast cancer allowed Complete resection required Total mastectomy or breast conserving surgery Adjuvant radiotherapy planned after protocol chemotherapy Clear surgical margins Axillary dissection yielding at least 9 lymph nodes Entry required within 8 weeks of definitive surgery Hormone receptor status: Any status

PATIENT CHARACTERISTICS: Age: Over 18 Sex: Not specified Menopausal status: Not specified Performance status: Karnofsky 80%-100% ECOG 0 or 1 Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no greater than 1.5 times normal AST no greater than 2 times normal Alkaline phosphatase no greater than 2 times normal Renal: Creatinine no greater than 1.8 mg/dL OR Creatinine clearance at least 60 mL/min Urinalysis normal Cardiovascular: Left ventricular ejection fraction normal on MUGA or echocardiogram No congestive heart failure requiring medical therapy No serious arrhythmia No first-, second-, or third-degree heart block Other: No abnormal CT of chest or abdomen No uncontrolled infection No serious medical condition that would prevent treatment No second malignancy except curatively treated: Nonmelanomatous skin cancer Carcinoma in situ of the cervix Not pregnant Negative pregnancy test Barrier contraception required of fertile patients before, during, and for 6 months after protocol therapy

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior systemic chemotherapy Endocrine Therapy: No concurrent hormonal therapy unless unrelated to cancer Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics Other: No concurrent medication affecting conduction unless cleared by a cardiologist, e.g.: Beta blockers Digoxin Antiarrhythmia agents Calcium channel blockers

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** New Haven

**Country:** United States

**Facility:** Yale Comprehensive Cancer Center

**State:** Connecticut

**Zip:** 06520-8028

#### Overall Officials

**Official 1:**

**Affiliation:** Yale University

**Name:** Maysa Abu-Khalaf, MD

**Role:** STUDY_CHAIR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000001941

- Term: Breast Diseases

- ID: D000012871

- Term: Skin Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5220

- Name: Breast Neoplasms

- Relevance: HIGH

- As Found: Breast Cancer

- ID: M20665

- Name: Breast Neoplasms, Male

- Relevance: LOW

- As Found: Unknown

- ID: M5218

- Name: Breast Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T861

- Name: Breast Cancer, Male

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001943

- Term: Breast Neoplasms

### Intervention Browse Module - Ancestors

- ID: D000000972

- Term: Antineoplastic Agents, Phytogenic

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000050257

- Term: Tubulin Modulators

- ID: D000050256

- Term: Antimitotic Agents

- ID: D000050258

- Term: Mitosis Modulators

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000007166

- Term: Immunosuppressive Agents

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018501

- Term: Antirheumatic Agents

- ID: D000018906

- Term: Antineoplastic Agents, Alkylating

- ID: D000000477

- Term: Alkylating Agents

- ID: D000019653

- Term: Myeloablative Agonists

- ID: D000000903

- Term: Antibiotics, Antineoplastic

- ID: D000059005

- Term: Topoisomerase II Inhibitors

- ID: D000059003

- Term: Topoisomerase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000004965

- Term: Estrogen Antagonists

- ID: D000006727

- Term: Hormone Antagonists

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

- ID: D000018931

- Term: Antineoplastic Agents, Hormonal

- ID: D000020845

- Term: Selective Estrogen Receptor Modulators

- ID: D000020847

- Term: Estrogen Receptor Modulators

- ID: D000050071

- Term: Bone Density Conservation Agents

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: BDCA

- Name: Bone Density Conservation Agents

- Abbrev: AnCoag

- Name: Anticoagulants

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: Ot

- Name: Other Dietary Supplements

### Intervention Browse Module - Browse Leaves

- ID: M19537

- Name: Paclitaxel

- Relevance: HIGH

- As Found: Surgery

- ID: M231

- Name: Albumin-Bound Paclitaxel

- Relevance: LOW

- As Found: Unknown

- ID: M6727

- Name: Cyclophosphamide

- Relevance: HIGH

- As Found: Cycle

- ID: M7492

- Name: Doxorubicin

- Relevance: HIGH

- As Found: Influenza

- ID: M227339

- Name: Liposomal doxorubicin

- Relevance: HIGH

- As Found: Influenza

- ID: M1945

- Name: Lenograstim

- Relevance: LOW

- As Found: Unknown

- ID: M16403

- Name: Tamoxifen

- Relevance: HIGH

- As Found: Castration-Resistant Prostate Cancer

- ID: M21320

- Name: Citric Acid

- Relevance: LOW

- As Found: Unknown

- ID: M1837

- Name: Sodium Citrate

- Relevance: LOW

- As Found: Unknown

- ID: M26197

- Name: Tubulin Modulators

- Relevance: LOW

- As Found: Unknown

- ID: M26196

- Name: Antimitotic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M10212

- Name: Immunosuppressive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

- ID: M20604

- Name: Antirheumatic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20942

- Name: Antineoplastic Agents, Alkylating

- Relevance: LOW

- As Found: Unknown

- ID: M3820

- Name: Alkylating Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4224

- Name: Antibiotics, Antitubercular

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M8116

- Name: Estrogens

- Relevance: LOW

- As Found: Unknown

- ID: M8114

- Name: Estrogen Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M30483

- Name: Estrogen Receptor Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M20966

- Name: Antineoplastic Agents, Hormonal

- Relevance: LOW

- As Found: Unknown

- ID: M22599

- Name: Estrogen Receptor Modulators

- Relevance: LOW

- As Found: Unknown

- ID: M22597

- Name: Selective Estrogen Receptor Modulators

- Relevance: LOW

- As Found: Unknown

- ID: T382

- Name: Citrate

- Relevance: HIGH

- As Found: Free

### Intervention Browse Module - Meshes

- ID: D000013629

- Term: Tamoxifen

- ID: D000017239

- Term: Paclitaxel

- ID: D000003520

- Term: Cyclophosphamide

- ID: D000004317

- Term: Doxorubicin

- ID: C000506643

- Term: Liposomal doxorubicin

### Misc Info Module

- Version Holder: 2024-05-24
