Phase III study of N, N-Diethyl-2-[4-(Phenylmethyl) Phenoxyl] Ethanamine (BMS-2173801-01) combined with doxorubicin versus doxorubicin alone in metastatic/recurrent breast cancer: National Cancer Institute of Canada Clinical Trials Group Study MA-19

2004 ◽  
Vol 4 (2) ◽  
pp. 125-126
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
National Cancer Institute ◽  
Recurrent Breast Cancer ◽  
Phase Iii ◽  
Phase Iii Study ◽  
Recurrent Breast

Phase III Comparative Study of Vinorelbine Combined With Doxorubicin Versus Doxorubicin Alone in Disseminated Metastatic/Recurrent Breast Cancer: National Cancer Institute of Canada Clinical Trials Group Study MA8

2000 ◽  
Vol 18 (12) ◽  
pp. 2385-2394 ◽  
Author(s):  
B. Norris ◽  
K.I. Pritchard ◽  
K. James ◽  
J. Myles ◽  
K. Bennett ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Vinca Alkaloid ◽  
Metastatic Breast ◽  
Response Duration ◽  
Recurrent Breast Cancer ◽  
Phase Iii ◽  
Phase Iii Study ◽  
Grade 3 ◽  
Recurrent Breast

PURPOSE: This phase III study was performed to determine the superiority of doxorubicin (DOX) and vinorelbine (VNB) (arm 1) versus DOX alone (arm 2) in metastatic breast cancer (MBC) for overall survival (OS), time to treatment failure (TTF), toxicity, and quality of life (QOL). PATIENTS AND METHODS: Three hundred three patients were randomized to DOX 50 mg/m2 intravenously (IV) on day 1 and VNB 25 mg/m2 IV on days 1 and 8 (arm 1) or DOX 70 mg/m2 IV on day 1 (arm 2). Both regimens were given every 3 weeks until a cumulative DOX dose of 450 mg/m2. After 16 of the first 65 randomized patients experienced febrile neutropenia (FN), the doses were reduced to DOX 40 mg/m2 on day 1 and VNB 20 mg/m2 on days 1 and 8 versus DOX 60 mg/m2 on day 1. Eligible patients were vinca alkaloid and anthracycline naive. Chemotherapy was first-line or second-line for MBC. RESULTS: Three patients were ineligible. Thus, 300 patients were assessable for toxicity and to determine time to disease progression (TTP), TTF, and OS. Two hundred eighty-nine patients were assessable for response, and 99 responders were assessable for response duration (RD). The response rates, QOL, and median RD, TTP, and TTF were not significantly different between the arms. Median OS was 13.8 months for arm 1 versus 14.4 months for arm 2 (P = .4). Grade 3 or 4 granulocytopenia was equivalent in both arms but more grade 3/4 neurotoxicity, mild venous toxicity, and FN were seen on arm 1. CONCLUSION: The survival with DOX and VNB is not superior to DOX alone in MBC.

scholarly journals Dutch Breast Cancer Trialists' Group (BOOG)

2006 ◽  
Vol 9 (S1) ◽  
pp. 61-79
Author(s):  
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Metastatic Breast Cancer ◽  
Endocrine Therapy ◽  
Metastatic Breast ◽  
Phase Iii ◽  
List Type ◽  
First Line ◽  
Open Label ◽  
Phase Iii Study

This section provides current contact details and a summary of recent or ongoing clinical trials being coordinated by Dutch breast cancer trialists' group (BOOG). Clinical trials include:An open label randomized (inter)national multicenter comparative trial of 5 years adjuvant endocrine therapy with an LHRH agonist plus an aromatase inhibitor (goserelin + anastrozole) versus five courses FE90C chemotherapy followed by the same endocrine therapy in pre- or perimenopausal patients with hormone receptor-positive primary breast cancer (PRemenopausal Optimal Management IS Endocrine therapy). BOOG 2002-01/PROMISE. ISRCTN23561723Open label, comparative, randomized, multicenter, study of trastuzumab (Herceptin) given with docetaxel (Taxotere) versus sequential single agent therapy with trastuzumab followed by docetaxel as first-line treatment for metastatic breast cancer (MBC) patients with HER2neu overexpression. BOOG 2002-02/HERTAX ISRCTN13770586Micro-metastases and Isolated tumour cells: Robust and Relevant Or Rubbish? The MIRROR study in BREAST CANCER. BOOG 2003-03/ZonMW 3214Radiation dose intensity study in breast cancer in young women: a randomized phase III trial of additional dose to the tumor bed. BOOG 2004-01/Young Boost SRCTN45066831Microarray analysis in breast cancer to Tailor Adjuvant Drugs Or Regimens, a randomized phase III study. MATADOR, BOOG 2005-02, CKTO 2004-04 ISRCTN61893718A prospective randomised, open, multicentre, phase III study to assess different Durations of Anastrozole therapy after 2–3 years Tamoxifen as Adjuvant therapy in postmenopausal women with breast cancer. 2006-01/DATAA randomized, open-label phase III study of first line chemotherapy in elderly metastatic breast cancer patients, comparing intravenous pegylated liposomal doxorubicin with oral capecitabine; and the incorporation of a complete geriatric assessment. 2006-02/OMEGABOOG participation in International studies:. BOOG 2001-01/TEAM trial. BOOG 2001-02/AMAROS (EORTC 10981/22023). BOOG 2002-04/HERA (BIG 1-01/EORTC 10011/BO16348B). BOOG 2003-02 (BIG 1-02/IBCSG 27-02). BOOG 2003-04 (GBG 29). BOOG 2004-02/TBP (GBG 26, BIG 3-05). BOOG 2005-01/CASA (IBCSG 32-05/BIG 1-05). BOOG 2005-03/MINDACT (EORTC 10041, BIG 3-04). BOOG 2006-03/SUPREMO (BIG 2-04). BOOG 2006-04/Adjuvant lapatinib study (BIG 2-06/EGF106708)

Phase II Trial of N,N-Diethyl-2-[4-(phenylmethyl)phenoxy]ethanamine.HCl and Doxorubicin Chemotherapy in Metastatic Breast Cancer: A National Cancer Institute of Canada Clinical Trials Group Study

1999 ◽  
Vol 17 (11) ◽  
pp. 3431-3437 ◽  
Author(s):  
K. Khoo ◽  
L. Brandes ◽  
L. Reyno ◽  
A. Arnold ◽  
S. Dent ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Metastatic Breast Cancer ◽  
Phase Ii ◽  
National Cancer Institute ◽  
Response Rate ◽  
Phase Ii Trial ◽  
Single Agent ◽  
Metastatic Breast ◽  
Phase Iii

PURPOSE: This multicenter phase II trial investigated the efficacy and toxicity of a combination of the novel intracellular histamine antagonist, N,N-diethyl-2-[4-(phenylmethyl)phenoxy]ethanamine.HCl (DPPE), and doxorubicin in patients with anthracycline-naïve metastatic breast cancer. Preclinical models and early single institutional studies suggested DPPE could potentiate the cytotoxicity of doxorubicin. PATIENTS AND METHODS: Forty-two women, 32 to 77 years old (median, 59 years), with anthracycline-naïve metastatic breast cancer were treated. Patients may have had one previous regimen of nonanthracycline chemotherapy, either in the adjuvant or metastatic disease treatment setting. DPPE (6 mg/kg) was administered as an 80 minute intravenous infusion with doxorubicin (60 mg/m2) given intravenously over the last 20 minutes of the DPPE infusion. Patients were premedicated with an antiemetic and sedating regimen. The DPPE/doxorubicin treatment was given every 21 days for a maximum of seven cycles. RESULTS: All 42 patients were assessable. Overall, toxicity was comparable to that expected with doxorubicin alone, with the exception of DPPE-related motion sickness, mild hallucinations, and cerebellar signs at the time of the infusion. These CNS side effects were manageable in an ambulatory care setting, improved with subsequent cycles of treatment, and did not usually require hospitalization. Four patients developed febrile neutropenia. Thirty-five patients received four or more cycles of chemotherapy. The overall response rate was 52.5% (95% confidence interval, 36% to 68%), with 9.5% complete responses (n = 4), 43% partial responses (n = 18), and 38% of patients with stable disease (n = 16). CONCLUSION: The antitumour effects of DPPE/doxorubicin the 52.5% response rate seems encouraging, particularly in consideration of the fact that a recently reported randomized National Cancer Institute of Canada Clinical Trials Group trial using single-agent doxorubicin 60 mg/m2 in one of the treatment arms achieved a 31% response rate. Thus, a randomized phase III trial of doxorubicin versus doxorubicin plus DPPE is being conducted in this clinical setting.

New Enzyme-Targeting Radiosensitizer (KORTUC II) Treatment for Locally Advanced or Recurrent Breast Cancer

2021 ◽  
Author(s):  
Taiju Shimbo ◽  
Mio Nakata ◽  
Hiroto Yoshioka ◽  
Chikara Sato ◽  
Akihiro Hori ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Hydrogen Peroxide ◽  
Clinical Trials ◽  
Irradiation Dose ◽  
Locally Advanced ◽  
Sodium Hyaluronate ◽  
Recurrent Breast Cancer ◽  
Tumor Control ◽  
Recurrent Breast ◽  
Clinical Trials Registry

Abstract PurposeKochi Oxydol-Radiation Therapy for Unresectable Carcinomas II (KORTUC II) is currently the most widely used radiosensitizer in clinical use in Japan. Its use sensitizes tumors to radiation by injecting hydrogen peroxide into the tumors to neutralize antioxidant enzymes and, simultaneously, increase intratumor oxygen tension. KORTUC II has achieved significant local effects with no notable adverse events. We report on the cases where KORTUC II was used to treat patients with locally advanced breast cancer (LABC) or recurrent breast cancer (LRBC).Methods and MaterialsThirty patients treated with KORTUC II for LABC (n = 9) or LRBC (n = 21), who were followed up for at least 3 months after treatment, were included in the study. This sensitizer is a solution consisting of 0.83% sodium hyaluronate and 0.5% hydrogen peroxide by volume. The mixture was injected intratumorally several times during the treatment period under ultrasound guidance, just before RT doses. RT was administered for local control. The irradiation dose and extent fields were determined by the attending physicians considering patient factors. Maximum tumor shrinkage (MTS) was measured by Computed Tomography. The duration of loco-regional control (LC) and progression free survival (PFS) after the completion of RT were determined using the Kaplan–Meier method.ResultsThe median irradiation dose was 60.4 Gy3.5 (43.6–76.1 Gy3.5) based on the calculation of EQD2, and median total number of sensitizer treatments was 5 (2–7). The median MTS was 97.0%. Fifteen patients (50%) were assessed to have achieved a clinical complete response. The proportion of patients with LC at 1, 2, and 3 years was 100%, 94.7%, and 75.4%. The proportion with PFS after RT at 1 and 2 years was 59.0%, and 24.1%, respectively.ConclusionsKORTUC II treatment demonstrated high rates of local tumor control for LABC and LRBC. KORTUC II is expected to be an inexpensive and extremely promising RT with an excellent radio-sensitizing effect.Trial registrationOsaka Medical College Clinical Trials Registry, trial no. 1973, date. May 10, 2010UMIN Clinical Trials Registry, trial no. UMIN000003734, date. June 10, 2010

A randomised phase III cross-over study of tamoxifen versus megestrol acetate in advanced and recurrent breast cancer

1996 ◽  
Vol 32 (11) ◽  
pp. 1888-1892 ◽  
Author(s):  
N.S.A. Stuart ◽  
J. Warwick ◽  
G.R.P. Blackledge ◽  
D. Spooner ◽  
C. Keen ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Recurrent Breast Cancer ◽  
Megestrol Acetate ◽  
Phase Iii ◽  
Recurrent Breast

Phase III Study of N,N-Diethyl-2-[4-(Phenylmethyl) Phenoxy]Ethanamine (BMS-217380-01) Combined With Doxorubicin Versus Doxorubicin Alone in Metastatic/Recurrent Breast Cancer: National Cancer Institute of Canada Clinical Trials Group Study MA.19

2004 ◽  
Vol 22 (2) ◽  
pp. 269-276 ◽  
Author(s):  
Leonard Reyno ◽  
Lesley Seymour ◽  
Dongsheng Tu ◽  
Susan Dent ◽  
Karen Gelmon ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast ◽  
Progression Free Survival ◽  
Recurrent Breast Cancer ◽  
Phase Iii ◽  
Metastatic Breast Carcinoma ◽  
Significant Difference ◽  
Recurrent Breast

Purpose N,N-diethyl-2-[4-(phenylmethyl)phenoxy]ethanamine (DPPE; tesmilifene) is a novel agent that augments chemotherapy cytotoxicity in vitro and in vivo. A phase II trial combining DPPE and doxorubicin (DOX) in metastatic breast carcinoma showed increased response over that expected with DOX. We report a phase III trial comparing DOX with DPPE plus DOX in metastatic or recurrent breast cancer. Patients and Methods Anthracycline-naive women with measurable metastatic disease were randomly assigned to receive, every 21 days, either DOX 60 mg/m2 intravenously or DOX during the last 20 minutes of an 80-minute infusion of DPPE (5.3 mg/kg), in both cases to cumulative DOX doses of 450 mg/m2. Patients receiving DPPE were aggressively premedicated to ameliorate toxicity. End points included progression-free survival (PFS), response rate (RR), and response duration (RD), quality of life (QOL), toxicity, and overall survival (OS). Results A planned interim analysis failed to detect an RR difference more than 5%. The study was closed to additional accrual and all DPPE was discontinued. The final analysis was conducted as planned after 256 progression events (median follow-up, 20.5 months). There was no significant difference in RR, RD, or PFS between arms. DPPE plus DOX was statistically superior to DOX in OS (hazard ratio, 0.66; 95% CI, 0.48 to 0.91; P = .021). DPPE plus DOX was associated with more gastrointestinal and CNS toxicity. No consistent influence on QOL was detected. Conclusion This study demonstrated no advantage in RR, RD, or PFS but significantly superior OS for DPPE plus DOX. Additional studies of DPPE are warranted.

Incidence and Prognostic Impact of Amenorrhea During Adjuvant Therapy in High-Risk Premenopausal Breast Cancer: Analysis of a National Cancer Institute of Canada Clinical Trials Group Study—NCIC CTG MA.5

2005 ◽  
Vol 23 (25) ◽  
pp. 6002-6008 ◽  
Author(s):  
Wendy R. Parulekar ◽  
Andrew G. Day ◽  
Jon A. Ottaway ◽  
Lois E. Shepherd ◽  
Maureen E. Trudeau ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Clinical Trials ◽  
National Cancer Institute ◽  
Hazard Ratio ◽  
Phase Iii ◽  
Prognostic Impact ◽  
Random Assignment ◽  
Premenopausal Breast Cancer ◽  
Premenopausal Patients

Purpose To investigate the therapeutic impact of chemotherapy-induced amenorrhea in premenopausal patients with breast cancer. Patients and Methods We conducted a retrospective cohort study of a National Cancer Institute of Canada Clinical Trials Group phase III trial involving premenopausal patients randomized to receive cyclophosphamide, methotrexate, and fluorouracil (CMF), versus intensive cyclophosphamide, epirubicin, and fluorouracil (CEF). The objectives of our study were to describe the incidence of amenorrhea at 6 and 12 months post-random assignment and to determine the association of amenorrhea with relapse-free and overall survival. Results Data on 442 patients were used in our analyses. Despite the higher cumulative dose of cyclophosphamide in the CMF treatment arm, at 6 months post–random assignment, the rate of amenorrhea was higher in the CEF group (relative risk, 1.2; 95% CI, 1.0 to 1.3), with no difference at 12 months. In the receptor-positive subgroup, 6-month amenorrhea rates were not associated with prognosis. In contrast, amenorrhea at 12 months was significantly associated with relapse-free survival (hazard ratio, 0.51; 95% CI, 0.32 to 0.82; P = .005) and overall survival (hazard ratio, 0.40; 95% CI, 0.22 to 0.72; P = .002). Conclusion Late chemotherapy-induced amenorrhea seems to be associated with improved outcome in patients with premenopausal, receptor-positive breast cancer.

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