Trial Outcomes & Findings for Adjuvant Chemotherapy in Treating Women Who Have Undergone Resection for Relapsed Breast Cancer; Chemotherapy as Adjuvant for LOcally Recurrent Breast Cancer (NCT NCT00074152)

NCT ID: NCT00074152

Last Updated: 2017-06-16

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 162 participants
• Primary outcome timeframe: 5 years after randomization
• Results posted on: 2017-06-16

Participant Flow

Participant milestones

Measure	Observation Observation (+/- Radiation). Patients receive radiotherapy\* within 6 months after surgery. radiation therapy: Given within 6 months after surgery	Chemotherapy Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy. chemotherapy: Given within 10 weeks after surgery.
Overall Study STARTED	77	85
Overall Study COMPLETED	22	52
Overall Study NOT COMPLETED	55	33

Reasons for withdrawal

Measure	Observation Observation (+/- Radiation). Patients receive radiotherapy\* within 6 months after surgery. radiation therapy: Given within 6 months after surgery	Chemotherapy Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy. chemotherapy: Given within 10 weeks after surgery.
Overall Study Death	21	9
Overall Study Lack of Efficacy	34	24

Baseline Characteristics

Adjuvant Chemotherapy in Treating Women Who Have Undergone Resection for Relapsed Breast Cancer; Chemotherapy as Adjuvant for LOcally Recurrent Breast Cancer

Baseline characteristics by cohort

Measure	Arm I n=77 Participants Observation (+/- Radiation). Patients receive radiotherapy\* within 6 months after surgery. radiation therapy: Given within 6 months after surgery	Arm II n=85 Participants Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy. chemotherapy: Given within 10 weeks after surgery.	Total n=162 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	60 Participants n=5 Participants	71 Participants n=7 Participants	131 Participants n=5 Participants
Age, Categorical >=65 years	17 Participants n=5 Participants	14 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Female	77 Participants n=5 Participants	85 Participants n=7 Participants	162 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants	23 participants n=7 Participants	42 participants n=5 Participants
Region of Enrollment Hungary	17 participants n=5 Participants	16 participants n=7 Participants	33 participants n=5 Participants
Region of Enrollment Canada	15 participants n=5 Participants	16 participants n=7 Participants	31 participants n=5 Participants
Region of Enrollment Spain	9 participants n=5 Participants	11 participants n=7 Participants	20 participants n=5 Participants
Region of Enrollment Peru	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment Australia	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment South Africa	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment Netherlands	6 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants
Region of Enrollment Switzerland	6 participants n=5 Participants	10 participants n=7 Participants	16 participants n=5 Participants
Prior chemotherapy Yes	52 participants n=5 Participants	49 participants n=7 Participants	101 participants n=5 Participants
Prior chemotherapy No	25 participants n=5 Participants	36 participants n=7 Participants	61 participants n=5 Participants
Surgery for primary tumor Mastectomy	31 participants n=5 Participants	33 participants n=7 Participants	64 participants n=5 Participants
Surgery for primary tumor Breast conserving	46 participants n=5 Participants	52 participants n=7 Participants	98 participants n=5 Participants
Estrogen receptor (ER) status of the isolated local or regional recurrence Positive	48 participants n=5 Participants	56 participants n=7 Participants	104 participants n=5 Participants
Estrogen receptor (ER) status of the isolated local or regional recurrence Negative	29 participants n=5 Participants	29 participants n=7 Participants	58 participants n=5 Participants
Progesterone receptor (PgR) status of the isolated local or regional recurrence positive	35 participants n=5 Participants	44 participants n=7 Participants	79 participants n=5 Participants
Progesterone receptor (PgR) status of the isolated local or regional recurrence negative	40 participants n=5 Participants	39 participants n=7 Participants	79 participants n=5 Participants
Progesterone receptor (PgR) status of the isolated local or regional recurrence not available	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Location of isolated loco-regional recurrence (ILRR) Breast	41 participants n=5 Participants	47 participants n=7 Participants	88 participants n=5 Participants
Location of isolated loco-regional recurrence (ILRR) Mx scar/chest wall	26 participants n=5 Participants	27 participants n=7 Participants	53 participants n=5 Participants
Location of isolated loco-regional recurrence (ILRR) Regional lymph nodes	10 participants n=5 Participants	11 participants n=7 Participants	21 participants n=5 Participants
Menopausal Status at isolated loco-regional recurrence (ILRR) pre	14 participants n=5 Participants	20 participants n=7 Participants	34 participants n=5 Participants
Menopausal Status at isolated loco-regional recurrence (ILRR) post	63 participants n=5 Participants	65 participants n=7 Participants	128 participants n=5 Participants
Time from primary surgery to isolated loco-regional recurrence (ILRR) surgery	6.2 years n=5 Participants	5.0 years n=7 Participants	5.5 years n=5 Participants
Estrogen receptor (ER) status of primary tumor negative	20 participants n=5 Participants	27 participants n=7 Participants	47 participants n=5 Participants
Estrogen receptor (ER) status of primary tumor positive	47 participants n=5 Participants	49 participants n=7 Participants	96 participants n=5 Participants
Estrogen receptor (ER) status of primary tumor unknown	10 participants n=5 Participants	9 participants n=7 Participants	19 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 years after randomization

Outcome measures

Measure	Arm I n=77 Participants Observation (+/- Radiation). Patients receive radiotherapy\* within 6 months after surgery. radiation therapy: Given within 6 months after surgery	Arm II n=85 Participants Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy. chemotherapy: Given within 10 weeks after surgery.
Disease-free Survival	57 percentage of participants Interval 44.0 to 67.0	69 percentage of participants Interval 56.0 to 79.0

SECONDARY outcome

Timeframe: 5 years after randomization

Outcome measures

Measure	Arm I n=77 Participants Observation (+/- Radiation). Patients receive radiotherapy\* within 6 months after surgery. radiation therapy: Given within 6 months after surgery	Arm II n=85 Participants Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy. chemotherapy: Given within 10 weeks after surgery.
Overall Survival	76 percentage of participants Interval 63.0 to 85.0	88 percentage of participants Interval 77.0 to 94.0

SECONDARY outcome

Timeframe: 5 years after randomization

Tumor recurrence in the breast, lymph nodes or other areas of the body including bone, lung, liver, central nervous system, bone marrow

Outcome measures

Measure	Arm I n=77 Participants Observation (+/- Radiation). Patients receive radiotherapy\* within 6 months after surgery. radiation therapy: Given within 6 months after surgery	Arm II n=85 Participants Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy. chemotherapy: Given within 10 weeks after surgery.
Sites of First Failures Death, cause unknown	2 participants	0 participants
Sites of First Failures Failures	34 participants	24 participants
Sites of First Failures Deaths	21 participants	9 participants
Sites of First Failures Local or Regional	9 participants	6 participants
Sites of First Failures Distant	22 participants	15 participants
Sites of First Failures Soft Tissue	2 participants	0 participants
Sites of First Failures Bone	5 participants	8 participants
Sites of First Failures Viscera	15 participants	7 participants
Sites of First Failures Contralateral Breast	1 participants	1 participants
Sites of First Failures Secon (non-breast) Malignancy	0 participants	1 participants
Sites of First Failures Death without prior Cancer Event	0 participants	1 participants

Adverse Events

Arm I

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm II

Serious events: 12 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm I n=77 participants at risk Observation (+/- Radiation). Patients receive radiotherapy\* within 6 months after surgery. radiation therapy: Given within 6 months after surgery	Arm II n=85 participants at risk Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy. chemotherapy: Given within 10 weeks after surgery.
Infections and infestations Febrile neutropenia	0.00% 0/77 • From date patient provided informed consent until 4 weeks after study treatment completion, beyond 4 weeks after stopping study treatment any death or serious adverse event considered possibly related to previous study treatment (approximately 10 years)	3.5% 3/85 • Number of events 3 • From date patient provided informed consent until 4 weeks after study treatment completion, beyond 4 weeks after stopping study treatment any death or serious adverse event considered possibly related to previous study treatment (approximately 10 years)
Cardiac disorders Left ventricular dysfunction	0.00% 0/77 • From date patient provided informed consent until 4 weeks after study treatment completion, beyond 4 weeks after stopping study treatment any death or serious adverse event considered possibly related to previous study treatment (approximately 10 years)	1.2% 1/85 • Number of events 1 • From date patient provided informed consent until 4 weeks after study treatment completion, beyond 4 weeks after stopping study treatment any death or serious adverse event considered possibly related to previous study treatment (approximately 10 years)
Infections and infestations Pulmonary/upper respiratory infection	0.00% 0/77 • From date patient provided informed consent until 4 weeks after study treatment completion, beyond 4 weeks after stopping study treatment any death or serious adverse event considered possibly related to previous study treatment (approximately 10 years)	1.2% 1/85 • Number of events 1 • From date patient provided informed consent until 4 weeks after study treatment completion, beyond 4 weeks after stopping study treatment any death or serious adverse event considered possibly related to previous study treatment (approximately 10 years)
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/77 • From date patient provided informed consent until 4 weeks after study treatment completion, beyond 4 weeks after stopping study treatment any death or serious adverse event considered possibly related to previous study treatment (approximately 10 years)	1.2% 1/85 • Number of events 1 • From date patient provided informed consent until 4 weeks after study treatment completion, beyond 4 weeks after stopping study treatment any death or serious adverse event considered possibly related to previous study treatment (approximately 10 years)
Infections and infestations Diverticulitis	0.00% 0/77 • From date patient provided informed consent until 4 weeks after study treatment completion, beyond 4 weeks after stopping study treatment any death or serious adverse event considered possibly related to previous study treatment (approximately 10 years)	1.2% 1/85 • Number of events 1 • From date patient provided informed consent until 4 weeks after study treatment completion, beyond 4 weeks after stopping study treatment any death or serious adverse event considered possibly related to previous study treatment (approximately 10 years)
Blood and lymphatic system disorders Neutropenia	0.00% 0/77 • From date patient provided informed consent until 4 weeks after study treatment completion, beyond 4 weeks after stopping study treatment any death or serious adverse event considered possibly related to previous study treatment (approximately 10 years)	1.2% 1/85 • Number of events 1 • From date patient provided informed consent until 4 weeks after study treatment completion, beyond 4 weeks after stopping study treatment any death or serious adverse event considered possibly related to previous study treatment (approximately 10 years)
Gastrointestinal disorders Colitis	0.00% 0/77 • From date patient provided informed consent until 4 weeks after study treatment completion, beyond 4 weeks after stopping study treatment any death or serious adverse event considered possibly related to previous study treatment (approximately 10 years)	1.2% 1/85 • Number of events 1 • From date patient provided informed consent until 4 weeks after study treatment completion, beyond 4 weeks after stopping study treatment any death or serious adverse event considered possibly related to previous study treatment (approximately 10 years)
Cardiac disorders Cardiac ischemia	0.00% 0/77 • From date patient provided informed consent until 4 weeks after study treatment completion, beyond 4 weeks after stopping study treatment any death or serious adverse event considered possibly related to previous study treatment (approximately 10 years)	2.4% 2/85 • Number of events 2 • From date patient provided informed consent until 4 weeks after study treatment completion, beyond 4 weeks after stopping study treatment any death or serious adverse event considered possibly related to previous study treatment (approximately 10 years)
Nervous system disorders Motor neuropathy	0.00% 0/77 • From date patient provided informed consent until 4 weeks after study treatment completion, beyond 4 weeks after stopping study treatment any death or serious adverse event considered possibly related to previous study treatment (approximately 10 years)	1.2% 1/85 • Number of events 1 • From date patient provided informed consent until 4 weeks after study treatment completion, beyond 4 weeks after stopping study treatment any death or serious adverse event considered possibly related to previous study treatment (approximately 10 years)
Reproductive system and breast disorders Endometrial mucosa thinkening	0.00% 0/77 • From date patient provided informed consent until 4 weeks after study treatment completion, beyond 4 weeks after stopping study treatment any death or serious adverse event considered possibly related to previous study treatment (approximately 10 years)	1.2% 1/85 • Number of events 1 • From date patient provided informed consent until 4 weeks after study treatment completion, beyond 4 weeks after stopping study treatment any death or serious adverse event considered possibly related to previous study treatment (approximately 10 years)

Other adverse events

Adverse event data not reported

Additional Information

Barbara Ruepp

International Breast Cancer Study Goup

Phone: +4131 3899222

Email: barbara.ruepp@ibcsg.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place