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8 Continuous vs 8 Intermittent Cycles in First and Second Line in HER2/Neu Neg Metastatic Breast Cancer (Stop&Go)

B

Borstkanker Onderzoek Groep

Status and phase

Completed
Phase 3

Conditions

Metastatic Breast Cancer
Human Epidermal Growth Factor 2 Negative Carcinoma of Breast

Treatments

Drug: Paclitaxel, Bevacizumab, liposomal doxorubicin, Capecitabine

Study type

Interventional

Funder types

NETWORK
Industry

Identifiers

NCT01935492
NTR2589 (Registry Identifier)
BOOG 2010-02 Stop&Go study

Details and patient eligibility

About

An open randomized phase III study to compare 8 continuous cycles of chemotherapy with 8 cycles of intermittent (2 times 4 cycles) chemotherapy in first line treatment, in combination with bevacizumab, and second line treatment of patients with HER2/neu negative, incurable, metastatic or unresectable locally advanced breast cancer.

Full description

The primary goal of this non-inferiority trial is to determine if the results obtained with a intermittent chemotherapy regimen (2 x 4 cycles of paclitaxel) are not inferior to the results of a continuous chemotherapy regimen (8 cycles of paclitaxel), both combined with bevacizumab in first line treatment of patients with HER2/neu negative, incurable, metastatic or unresectable locally advanced breast cancer.

Enrollment

420 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Female patients ≥ 18 years old.
  • Patients with HER2/neu negative, incurable, metastatic or unresectable locally advanced breast cancer, who are candidates for chemotherapy.
  • Patients with measurable or evaluable-only (RECIST 1.1)
  • Documented Estrogen Receptor (ER) / Progesteron Receptor (PR) status.
  • HER2/neu-negative disease
  • Patients with an ECOG Performance Status ≤ 2.
  • Life expectancy of > 12 weeks.
  • Signature of Informed Consent Form

Exclusion criteria

  • Previous chemotherapy for HER2/neu negative, incurable, metastatic or unresectable locally advanced breast cancer.
  • Prior hormonal therapy for HER2/neu negative, incurable, metastatic or unresectable locally advanced breast cancer that has not been discontinued 1 week before start of study treatment.
  • Prior adjuvant/neo-adjuvant chemotherapy within 6 months prior to first study treatment. However, if the prior adjuvant/neo-adjuvant chemotherapy was taxane based, patients are excluded if they received their last chemotherapy within12 months prior to first study treatment.
  • Prior radiotherapy covering more than 30% of marrow-bearing bone.
  • Patients that have received recent radiation therapy that are not recovered from any significant (Grade ≥ 3) acute toxicity prior to study treatment.
  • Prior therapy with bevacizumab, sorafenib, sunitinib, or other VEGF pathway-targeted therapy.
  • Chronic daily treatment with aspirin
  • Chronic daily treatment with corticosteroids, with the exception of inhaled steroids.
  • Current or recent treatment with another investigational drug or participation in another investigational study.
  • Inadequate bone marrow, liver, renal function
  • INR > 1.5 or an aPTT > 1.5 x ULN within 7 days prior to first study treatment.
  • Known CNS disease, except for treated brain metastases.
  • Patients with concurrent active malignancy
  • Pregnant or lactating
  • Women of childbearing potential not using effective, non-hormonal means of contraception
  • Major surgical procedure (including open biopsy) within 28 days prior to the first study treatment
  • Core biopsy or other minor surgical procedure, within 7 days prior to day 1.
  • Significant vascular disease within 6 months prior to day 1.
  • Any previous venous thrombo-embolism > CTC Grade 3.
  • History of haemoptysis
  • History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding.
  • Uncontrolled hypertension
  • Clinically significant (i.e. active) cardiovasculair disease
  • LVEF by MUGA or ECHO < 50%.
  • History of abdominal fistula, Grade 4 bowel obstruction or GI perforation, intra-abdominal abscess within 6 months of randomization.
  • Serious non-healing wound, peptic ulcer or bone fracture.
  • Known hypersensitivity to any of the study drugs or excipients.
  • Hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies.
  • Psychiatric illness, physical examination or laboratory findings that may interfer with protocol

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

420 participants in 2 patient groups

8 cycles of Paclitaxel & bevacizumab
Active Comparator group
Description:
8 cycles of Paclitaxel: 90 mg/m2 IV on days 1, 8 and 15 every 28 days \& Bevacizumab: 10 mg/kg IV on days 1 and 15 every 28 days
Treatment:
Drug: Paclitaxel, Bevacizumab, liposomal doxorubicin, Capecitabine
Drug: Paclitaxel, Bevacizumab, liposomal doxorubicin, Capecitabine
2 x 4 cycles of Paclitaxel & bevacizumab
Active Comparator group
Description:
intermittent 2x4 cycles of Paclitaxel: 90 mg/m2 IV on days 1, 8 and 15 every 28 days \& Bevacizumab: 10 mg/kg IV on days 1 and 15 every 28 days
Treatment:
Drug: Paclitaxel, Bevacizumab, liposomal doxorubicin, Capecitabine
Drug: Paclitaxel, Bevacizumab, liposomal doxorubicin, Capecitabine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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