A Phase 3 interventional study of chemotherapy and radiation therapy in Breast Cancer, sponsored by ETOP IBCSG Partners Foundation. Completed at 199 sites in 10 countries. Open to female participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2017-06-16.
Sponsored by ETOP IBCSG Partners Foundation · Phase 3, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether chemotherapy is effective in treating women who have undergone surgery and radiation therapy for relapsed breast cancer.
PURPOSE: Randomized phase III trial to determine the effectiveness of adjuvant chemotherapy in treating women who have undergone resection for local and/or regional relapsed breast cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior chemotherapy (yes vs no), estrogen receptor (ER) positive and/or progesterone receptor (PR) positive (yes vs no), and location of recurrence (breast vs mastectomy scar/chest wall vs regional lymph nodes). Patients are randomized to 1 of 2 treatment arms.
NOTE: *Patients with clear margins (R0) who received prior adjuvant radiotherapy are not required to receive further radiotherapy
Patients with ER and/or PR positive tumors also receive standard hormonal therapy.
Quality of life is assessed at baseline and at 9 and 12 months (QOL portion closed 11/13/08).
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 265 patients will be accrued for this study within 4 years.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 162 is above the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →ETOP IBCSG Partners Foundation is the lead sponsor of 50 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed invasive breast cancer
First local and/or regional (i.e., ipsilateral axillary or internal mammary lymph node region) recurrence after primary treatment with mastectomy or lumpectomy/quadrantectomy with clear surgical margins
Surgical resection of the recurrence meeting 1 of the following criteria:
No skeletal pain of unknown cause
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Patients receive radiotherapy\* within 6 months after surgery.
Radiation: radiation therapy
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.
Drug: chemotherapy
Given within 10 weeks after surgery.
Given within 6 months after surgery
Disease-free Survival
Time frame: 5 years after randomization
Overall Survival
Time frame: 5 years after randomization
Sites of First Failures
Tumor recurrence in the breast, lymph nodes or other areas of the body including bone, lung, liver, central nervous system, bone marrow
Time frame: 5 years after randomization
| Milestone | Observation | Chemotherapy |
|---|---|---|
| Started | 77 | 85 |
| Completed | 22 | 52 |
| Not completed | 55 | 33 |
| Withdrew: Death | 21 | 9 |
| Withdrew: Lack of efficacy | 34 | 24 |
| percentage of participants | Arm I | Arm II |
|---|---|---|
| Disease-free Survival | 57 (44 to 67) | 69 (56 to 79) |
| percentage of participants | Arm I | Arm II |
|---|---|---|
| Overall Survival | 76 (63 to 85) | 88 (77 to 94) |
Tumor recurrence in the breast, lymph nodes or other areas of the body including bone, lung, liver, central nervous system, bone marrow
| participants | Arm I | Arm II |
|---|---|---|
| Failures | 34 | 24 |
| Deaths | 21 | 9 |
| Local or Regional | 9 | 6 |
| Distant | 22 | 15 |
| Soft Tissue | 2 | 0 |
| Bone | 5 | 8 |
| Viscera | 15 | 7 |
| Contralateral Breast | 1 | 1 |
| Secon (non-breast) Malignancy | 0 | 1 |
| Death without prior Cancer Event | 0 | 1 |
| Death, cause unknown | 2 | 0 |
Collected over 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). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm I | — | 0/77 (0%) | 0/77 (0%) |
| Arm II | — | 12/85 (14.1%) | 0/85 (0%) |
| Event | Arm I | Arm II |
|---|---|---|
| Febrile neutropeniaInfections and infestations | 0/77 | 3/85 |
| Cardiac ischemiaCardiac disorders | 0/77 | 2/85 |
| Left ventricular dysfunctionCardiac disorders | 0/77 | 1/85 |
| Pulmonary/upper respiratory infectionInfections and infestations | 0/77 | 1/85 |
| Gastrointestinal painGastrointestinal disorders | 0/77 | 1/85 |
| DiverticulitisInfections and infestations | 0/77 | 1/85 |
| NeutropeniaBlood and lymphatic system disorders | 0/77 | 1/85 |
| ColitisGastrointestinal disorders | 0/77 | 1/85 |
| Motor neuropathyNervous system disorders | 0/77 | 1/85 |
| Endometrial mucosa thinkeningReproductive system and breast disorders | 0/77 | 1/85 |
| Age, Categorical(Participants) | Arm I | Arm II | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 60 | 71 | 131 |
| >=65 years | 17 | 14 | 31 |
| Sex: Female, Male(Participants) | Arm I | Arm II | Total |
|---|---|---|---|
| Female | 77 | 85 | 162 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Arm I | Arm II | Total |
|---|---|---|---|
| United States | 19 | 23 | 42 |
| Hungary | 17 | 16 | 33 |
| Canada | 15 | 16 | 31 |
| Spain | 9 | 11 | 20 |
| Peru | 1 | 0 | 1 |
| Australia | 1 | 1 | 2 |
| South Africa | 3 | 2 | 5 |
| Netherlands | 6 | 6 | 12 |
| Switzerland | 6 | 10 | 16 |
| Prior chemotherapy(participants) | Arm I | Arm II | Total |
|---|---|---|---|
| Yes | 52 | 49 | 101 |
| No | 25 | 36 | 61 |
| Surgery for primary tumor(participants) | Arm I | Arm II | Total |
|---|---|---|---|
| Mastectomy | 31 | 33 | 64 |
| Breast conserving | 46 | 52 | 98 |
| Estrogen receptor (ER) status of the isolated local or regional recurrence(participants) | Arm I | Arm II | Total |
|---|---|---|---|
| Positive | 48 | 56 | 104 |
| Negative | 29 | 29 | 58 |
| Progesterone receptor (PgR) status of the isolated local or regional recurrence(participants) | Arm I | Arm II | Total |
|---|---|---|---|
| positive | 35 | 44 | 79 |
| negative | 40 | 39 | 79 |
| not available | 2 | 2 | 4 |
| Location of isolated loco-regional recurrence (ILRR)(participants) | Arm I | Arm II | Total |
|---|---|---|---|
| Breast | 41 | 47 | 88 |
| Mx scar/chest wall | 26 | 27 | 53 |
| Regional lymph nodes | 10 | 11 | 21 |
3 further baseline measures are reported on the registry.
Showing the first 100 of 199 sites across 10 countries.
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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ETOP IBCSG Partners Foundation