Phase II Trial of BIBW 2992 in Patients With HER2-positive Metastatic Breast Cancer After Failure of Trastuzumab Therapy

Breast Neoplasms Clinical Trial

Official title:

Phase II Trial of BIBW 2992 in Patients With HER2-positive Metastatic Breast Cancer After Failure of Trastuzumab Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00431067
• Other study ID #: 1200.11
• Secondary ID: 2007-004805-80
• Status: Completed
• Phase: Phase 2
• First received: February 2, 2007
• Last updated: June 3, 2014
• Start date: September 2006

Study information

• Verified date: November 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Great Britain: EMEAUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary objective of this trial is to explore the efficacy of BIBW 2992 in HER2 positive metastatic breast cancer patients after failure of trastuzumab containing regimens.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

Inclusion Criteria:

1. Male or female patients with confirmed diagnosis of Stage IIIB or IV HER2-positive metastatic breast cancer(HER2 2+ and FISH positive or HER2 3+).

2. Patients must have progressed following receipt of prior standard trastuzumab treatment or standard chemotherapy in conjunction with trastuzumab. Patients with visceral disease or rapid progression should not be included if they have not had previous chemotherapy in addition to trastuzumab. Patients who are intolerant to trastuzumab and who have received adequate chemotherapy and/or hormone therapy are eligible upon progression.

3. Age 18 years or older.

4. Life expectancy of at least four (4) months.

5. Written informed consent that is consistent with ICH-GCP guidelines.

6. Eastern Cooperative Oncology Group (ECOG, R01-0787) performance Score 0, 1 or 2.

7. Patients should not have received treatment with chemotherapy or immune therapy within the last 4 weeks (2 weeks for trastuzumab). Patients should not have received treatment with hormone therapy within the last 2 weeks.

8. Patients must have recovered from any therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapies to CTC less than or equal to Grade 1.

9. Patients must have recovered from previous surgery.

10. Patients must have measurable disease as defined by RECIST criteria.

Exclusion criteria:

Exclusion Criteria:

1. Active infectious disease.

2. Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhea.

3. Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol.

4. Patients with active/symptomatic brain metastases. Patients with a history of treated brain metastases must have stable or normal MRI scan at screening and be at least three months post-radiation or surgery.

5. Cardiac left ventricular function with resting ejection fraction <50%.

6. Absolute neutrophil count (ANC) less than 1500 cells/mm3.

7. Platelet count less than 100 000 cells/mm3.

8. Bilirubin greater than 1.5 mg/dl (>26 micromol /L, SI unit equivalent).

9. Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than three times the upper limit of normal.

10. Serum creatinine greater than 1.5 mg/dl (>132 micromol/L, SI unit equivalent).

11. Women and men (and their partners) who are sexually active and unwilling to use a medically acceptable method of contraception.

12. Pregnancy or breast-feeding.

13. Treatment with other investigational drugs; chemotherapy, immunotherapy, radiotherapy or hormone therapy (including LHRH agonists, or other hormones taken for breast cancer), or participation in another clinical study within the past 4 weeks before start of therapy or concomitantly with this study. Treatment with bisphosphonates is allowed.

14. Prior treatment with an EGFR- or HER2 inhibiting drug (except trastuzumab).

15. Patients unable to comply with the protocol.

16. Active alcohol or drug abuse.

17. Patients with history of other malignancy (except for appropriately treated superficial basal cell skin cancer and surgically cured cervical cancer in situ) unless free of disease for at least 3 years.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• BIBW 2992

Locations

Country	Name	City	State
United Kingdom	1200.11.4401 Boehringer Ingelheim Investigational Site	Bournemouth
United Kingdom	1200.11.4402 Boehringer Ingelheim Investigational Site	Crownhill, Plymouth
United Kingdom	1200.11.4406 Boehringer Ingelheim Investigational Site	Guildford
United Kingdom	1200.11.4405 Boehringer Ingelheim Investigational Site	London
United Kingdom	1200.11.4404 Boehringer Ingelheim Investigational Site	Poole
United Kingdom	1200.11.4403 Boehringer Ingelheim Investigational Site	Truro
United States	1200.11.1 Boehringer Ingelheim Investigational Site	Boston	Massachusetts
United States	1200.11.5 Boehringer Ingelheim Investigational Site	Chapel Hill	North Carolina
United States	1200.11.7 Boehringer Ingelheim Investigational Site	Encinitas	California
United States	1200.11.4 Boehringer Ingelheim Investigational Site	Santa Monica	California
United States	1200.11.3 Boehringer Ingelheim Investigational Site	Scottsdale	Arizona
United States	1200.11.2 Boehringer Ingelheim Investigational Site	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response (OR)	Objective response (OR) including complete response (CR) and partial response (PR) according to the Response Evaluation Criteria in Solid Tumours (RECIST) criteria .	From first dose of study medication to response measurement, up to 34 month	No
Secondary	Progression Free Survival (PFS)	PFS was defined as the time from the first treatment to the occurrence of tumour progression or death, whichever came first. It was assessed according to RECIST criteria.	From first dose of study medication to the occurrence of progression or death whichever came first, up to 34 month	No
Secondary	Overall Survival (OS)	OS was defined as the time from first treatment to death or to the last date the patient was known to be alive.	From first dose of study medication to death or to the last date the patient was known to be alive, up to 34 month	No
Secondary	Time to RECIST Tumour Reponse	The time to OR was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST criteria.	From first dose of study medication to time when OR measurement was taken.	No
Secondary	Duration of Confirmed OR	Duration of confirmed OR is measured from the time of first OR to the time of progression or death (or date of censoring for progression free survival).	From first OR to time of progression or death	No

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