TRIal evalUating the Menstrual and Ovarian Function of Young Breast Cancer Patients Treated With a cycloPHosphamide-free Regimen

NCT ID: NCT02053597

Last Updated: 2015-09-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-07-31

Brief Summary

Recently, there has been a rising trend of delaying childbearing and hence more women are diagnosed with breast cancer before completing their families. Given the continuous decline in recurrences and death secondary to breast cancer and the reassuring data on the safety of pregnancy following breast cancer more women are inquiring into the possibility of preserving fertility following chemotherapy. The challenge remains in using a regimen that is devoid of cyclophosphamide, but is as effective as the standard regimens that incorporate cyclophosphamide. The combination doxorubicin (50 mg/m2) and paclitaxel (200 mg/m2) (AP) followed by 12 weeks of paclitaxel (80 mg/m2) (P) emerges as a treatment option with convincing results regarding its effectiveness in the early setting, and could be potentially associated with less ovarian toxicity being devoid of cyclophosphamide.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

doxorubicin and paclitaxel

All patients will receive four cycles of doxorubicin (A) (50 mg/m2) and paclitaxel (P) (200 mg/m2), given on a three-weekly basis for four cycles, followed by weekly paclitaxel (P) (80 mg/m2) for twelve weeks.

Group Type: EXPERIMENTAL

Doxorubicin

Intervention Type: DRUG

All patients will receive four cycles of doxorubicin (A) (50 mg/m2)

paclitaxel

Intervention Type: DRUG

All patients will receive four cycles paclitaxel (P) (200 mg/m2), given on a three-weekly basis for four cycles, followed by weekly paclitaxel (P) (80 mg/m2) for twelve weeks.

Interventions

Doxorubicin

All patients will receive four cycles of doxorubicin (A) (50 mg/m2)

Intervention Type: DRUG

paclitaxel

All patients will receive four cycles paclitaxel (P) (200 mg/m2), given on a three-weekly basis for four cycles, followed by weekly paclitaxel (P) (80 mg/m2) for twelve weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age ≤ 40 years.

2. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.

3. Non-metastatic primary invasive carcinoma of the breast eligible for adjuvant or neoadjuvant chemotherapy.

4. Negative estrogen (ER) and progesterone receptor (PgR) status.

5. Baseline left ventricular ejection fraction (LVEF) ≥50% measured by an echocardiogram or MUGA.

6. Interested in maintaining menstrual and/or ovarian function following completion of chemotherapy.

7. Known HER2/neu status.

8. Negative pregnancy test within 14 days prior to starting chemotherapy.

9. Adequate hematologic, hepatic and renal function.

10. Signed informed consent.

Exclusion Criteria

1. History of prior malignant disease (breast or non-breast) or non-malignant condition which was treated with chemotherapy, pelvic irradiation or any therapy that could potentially affect ovarian function.

2. Previous history of amenorrhea > 3 months within the last 2 years (excluding pregnancy).

3. Ovarian insufficiency defined as serum FSH > 20 IU/L at the local laboratory, anytime during the menstrual cycle.

4. Any ovarian pathology or abnormalities at the screening pelvic ultrasound, except for functional follicular cysts.

5. Pregnant or breastfeeding patients.

6. Inability or unwillingness to use effective contraception during and up to 3 months after the last dose of study medication. Effective methods include the following: non-hormonal intrauterine device, barrier method - condoms, diaphragm - also in conjugation with spermicidal jelly, or total abstinence. Oral, injectable, or implant hormonal contraceptives are not allowed.

7. Concurrent use of any other cytotoxic or hormonal agent, namely GnRH agonists.

8. Prior pre-existing peripheral neuropathy of any cause, including diabetes mellitus, alcohol abuse, HIV infection, autoimmune and hereditary neuropathies, amyloidosis, hypothyroidism, vitamin deficiencies.

9. Serious cardiac illness, uncontrolled hypertension or medical condition that would affect administration of chemotherapy and compliance to study procedures.

10. Known sensitivity to any of the study medications.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jules Bordet Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daphné Tkint de Roodenbeke, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Jules Bordet Institute

Hatem Azim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Jules Bordet Institute

Isabelle Demeestere, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

H.U.B Erasme

Locations

Jules Bordet Institute

Brussels, Brussels Capital, Belgium

Hôpital Erasme

Brussels, Brussels Capital, Belgium

Clinique et Maternité Sainte Elisabeth

Namur, Namur, Belgium

GZA Ziekenhuisen Campus Sint-Augustinus - Iridium Kankernetwerk

Antwerp, Wilrijk, Belgium

Countries

Belgium

Other Identifiers

2013-000173-77

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CE2142

Identifier Type: -

Identifier Source: org_study_id