Maintenance Versus Observation After 6 Cycles of Gemcitabine Plus Paclitaxel in Pts With Advanced Breast Cancer

NCT00561119 | Completed Phase 3 DMC

• 1 other identifier: 2007-03-003
• Study Type: interventional
• Target: 326
• Locations: 1 country
• Sites: 15

Brief Summary

The primary goal of therapy in patients with metastatic breast cancer is palliation and prolongation of life with quality. Although there are no randomized trials comparing chemotherapy with supportive care in women with metastatic breast cancer, chemotherapy clearly provides a survival benefit in metastatic breast cancer. Due to diagnosis at earlier phases of metastatic disease and more effective therapies, the median survival of patients treated with modern taxane-based chemotherapy is now reaching approximately 2 years. The duration of chemotherapy in patients responding or stable disease remains controversial, since quality of life is not usually adversely affected and may even be improved in many patients receiving cytotoxic chemotherapy. In addition, many commonly used chemotherapeutic agents are not limited by cumulative toxicity in metastatic breast cancer patients. Several studies investigated the role of maintenance chemotherapy suggest that maintenance chemotherapy is associated with superior time to progression but no survival gain. However, these randomized trials did not incorporate taxane-based chemotherapeutic regimens, the new standard of care in metastatic breast cancer patients these days. A 1998 metaanalysis of 1,986 patients randomly assigned between combination chemotherapy and single-agent therapy in metastatic breast cancer patients demonstrated a survival advantage to combination chemotherapy, with a hazard ratio of 0.82 (range, 0.75 to 0.90). Although there are several randomized trials showing negative results for survival gain in patients who received maintenance chemotherapy, the role of maintenance chemotherapy with newer agents, such as docetaxel or paclitaxel, have not been established yet. Although Italian MANTA trial demonstrated no difference in PFS or survival between the two arms, their metaanalysis advocated survival benefit of maintenance therapy. Since gemcitabine/paclitaxel (GP) combination chemotherapy is one of the two regimens which showed definite survival gain with favorable toxicity from a randomized trial, we plan to randomize patients who responded to six cycles of GP induction chemotherapy to receive additional maintenance GP chemotherapy until disease progression versus observation. We hypothesize that patients who receive maintenance GP chemotherapy will do better in terms of progression free survival.

Conditions

Advanced Breast Cancer

Keywords

maintenance chemotherapy; metastatic or recurrent breast cancer; gemcitabine; paclitaxel(GP)

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  approximately 4 years

Secondary Outcomes (1)

• a) overall survival b) quality of life c) toxicity of GP chemotherapy d) duration of response

  approximately 4 years

Study Arms (2)

Arm 1

NO INTERVENTION

Observation after 6 cycles of gemcitabine plus paclitaxel till progression

Arm 2

EXPERIMENTAL

Maintenance chemotherapy with gemcitabine plus paclitaxel after 6 cycles of gemcitabine plus paclitaxel till progression

Drug: gemcitabine , paclitaxel

Interventions

gemcitabine , paclitaxel DRUG

Gemcitabine 1250 mg/m2 i.v. Day 1 \& 8 Paclitaxel 175 mg/m2 i.v. day 1 repeat every 3 weeks

Arm 2

Eligibility Criteria

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

You may qualify if:

• Histologically Confirmed Metastatic, or Recurrent Breast Cancer
• Age over 18 Years
• ECOG Performance Status 0-2
• Premenopausal or Postmenopausal Breast Cancer Patients With Measurable or Non-Measurable Lesions, Who Are Candidates for Chemotherapy
• Life Expectancy ≥ 3 Months
• Patients May Have Received Prior Neoadjuvant or Adjuvant Taxane Regimen as Long as it Has Been 12 Months Since Completion of Regimen.
• Patients Either May or May Not Have a Prior Anthracycline Containing Regimen.
• Prior Hormonal Therapy as a Treatment of Metastatic Disease is Allowed. But Antitumoral Hormonal Therapy Must be Terminated Prior to Enrollment(up to the Date of Randomization)
• Prior Radiation Therapy Allowed as Long as \< 25% of the Bone Marrow Has Been Treated,and the Patients Must Have Recovered From the Acute Toxic Effects of the Treatment Prior to Study Enrollment.Prior Radiation to the Whole Pelvis is Not Allowed. Prior Radiotherapy Must be Completed 4 Weeks Before Study Entry.
• Adequate Bone Marrow Function (≥ ANC 1,500/ul, ≥ Platelet 100,000/ul, ≥ Hemoglobin 9.0 g/dl)
• Adequate Renal Function (≤ Serum Creatinine 1.5 mg/dl or CCr ≥ 50 ml/Min)
• Adequate Liver Function (≤ Serum Bilirubin 1.5 mg/dl, ≤ AST/ALT x 3 Upper Normal Limit)
• No Prior History of Chemotherapy for Metastatic, Recurrent Breast Cancer
• Written Informed consent.

You may not qualify if:

• Serious Uncontrolled Intercurrent Infections
• Serious Intercurrent Medical or Psychiatric Illness, Including Active Cardiac Disease
• Pregnancy or Breast Feeding
• Second Primary Malignancy(Except Cancer of Cervix or Skin or Other Malignancy Treated at Least 5 Years Previously With no Evidence of Recurrence)
• Documented Parenchymal or Leptomeningeal Brain Metastasis
• Peripheral Neuropathy ≥ Grade 2
• Prior Treatment With Gemcitabine Will Not be Allowed.
• HER-2 Overexpressing Breast Cancer and Concomitant Trastuzumab Treatment is Not Allowed

Sponsors & Collaborators

• Samsung Medical Center: lead
• Korean Cancer Study Group: collaborator

Study Sites (15)

Ajou University University Hospital

Suwon, Gyeonggi-do, South Korea

Location

Hanlym University Hospital

Anyang, Kyeongki-Do, 431-070, South Korea

Location

Bundang Seoul National University Hospital

Bundang, Kyeongki-Do, 463-707, South Korea

Location

Yeungnam University Hospital

Kyungsan, Kyungsangbuk-Do, South Korea

Location

Daegu Patima Hospital

Daegu, 701-600, South Korea

Location

Inha University School of Medicine

Inchon, 400-711, South Korea

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Yonsei University Hospital

Seoul, 120-752, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

National Cancer Center

Seoul, 140-320, South Korea

Location

Kunkuk University Hospital

Seoul, 143-729, South Korea

Location

Ewha University Hospital

Seoul, 911-1, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Soonchunhyang University Hospital

Seoul, South Korea

Location

Ulsan University Hospital

Ulsan, 682-714, South Korea

Location

Related Publications (1)

• Park YH, Jung KH, Im SA, Sohn JH, Ro J, Ahn JH, Kim SB, Nam BH, Oh DY, Han SW, Lee S, Park IH, Lee KS, Kim JH, Kang SY, Lee MH, Park HS, Ahn JS, Im YH. Phase III, multicenter, randomized trial of maintenance chemotherapy versus observation in patients with metastatic breast cancer after achieving disease control with six cycles of gemcitabine plus paclitaxel as first-line chemotherapy: KCSG-BR07-02. J Clin Oncol. 2013 May 10;31(14):1732-9. doi: 10.1200/JCO.2012.45.2490. Epub 2013 Apr 8.

  PMID: 23569309 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis; Breast Neoplasms

Interventions

Gemcitabine; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Young-Hyuck Im, M.D., Ph.D

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

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: Professor

Study Record Dates

• First Submitted: November 18, 2007
• First Posted: November 20, 2007
• Study Start: May 1, 2007
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 1, 2017

Record last verified: 2017-04

Locations

KR (15)